Www.ebmt.org M C Ruiz de Elvira April, 2012 Basic Transplant Registration Data submission and the Med-A

www.ebmt.org

M C Ruiz de Elvira April, 2012

Basic Transplant Registration

Data submission and the Med-A

The European Group for Blood and Marrow Transplantation The European Group for Blood and Marrow Transplantationwww.ebmt.org

Introduction

• Why report to the EBMT?• What should be reported? • Where, when and how?

• Quick overview of the main items

• Tools & advice for the registration process

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Why report to the EBMT (1)

-> Essential tool to assess outcome of all transplants

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Own databaseRegulatory

requirementsAccreditation Auditing Research

Centres National Registries

EBMT Donor Registries

Health Authorities


Why report to the EBMT? (2)

Refer to the EBMT registry slides:...Data-Management/Helpdesk/Documents/

2011EBMTRegistry.pdf

to get the annual number of registrations and the breakdown by disease and type of

transplant

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http://www.ebmt.org/4Registry/registry5.html


What should be reported?

EBMT reporting centres must record every consecutive transplant done in their centre

– MED-A (~80-150 items) is mandatory for all HSCT. It is not sufficient to perform scientific studies

– MED-B (~500 items) is mandatory for allografts in some countries

For research, MED-B is almost always essential

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Who should report?

A centre must fill in a MED-AB Registration form only if the transplant procedure was actually performed at that centre.

The centre should not fill in the MED-AB Registration form if they have acted as:

–only as a referral centre

– the follow up centre

– the harvest centre

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Which procedure should be reported on a HSCT MED-AB form?

A MED-AB Registration form should be filled in for a procedure in which a patient has received haematopoietic stem cells capable of long term survival or of self renewal

The EBMT has adopted the following definition for haematopoietic stem cell transplant (HSCT):

Transfer of stem cells, defined as progenitor cells with repopulating capacity and the potential to sustain long term haematopoiesis, within one person or from one person to another, in a dose that is sufficient to reconstitute haematopoiesis in all lineages

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Which procedure should not be reported on a HSCT MED-AB form? (1)

A new MED-AB Registration form should not be used if:

• The sole purpose of the procedure is to reduce a period of neutropenia after a chemotherapy treatment unlikely to cause troublesome neutropenia

or:• The procedure consists of the re-infusion of

autologous peripheral blood progenitor cells as a rescue for a failed graft (backup)

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Which procedure should not be reported on a HSCT MED-AB form? (2)

A new MED-AB Registration form should not be used if:

The aim of the cell infusion is a donor lymphocyte or cytokine activated killer cells infusion given after the first 100 days post HSCT. The Donor Cell Infusion section at the end of the MED-A Follow Up form or within the Med-B Follow Up forms should be used for this

or:

The aim of the cell infusion is not a haematopoietic transplant or a donor lymphocyte infusion (DLI). In this case, please fill in the Cell Therapy MED-A form.

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2 ways of reporting data:The person responsible for Data management at centre

level, with the help of the treating physician, will

• Enter data directly into the Registry database using “ProMISe”:

• Complete the MED-AB paper forms and send them to:

– their Integrated National Registry in charge of entering the data into the Registry database:

Austria, Czech Republic, Germany, Italy, The Netherlands, Switzerland, Turkey, United Kingdom

– the EBMT Registry Office otherwise

Where to report MED-AB data?

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When should forms be completed?

The Registration form with –at least one Disease classification sheet, if Med-A–an allograft or autograft insert, if Med-B

must be received by the EBMT:

•as soon as possible after 100 days post HSCTor •after the patient has died, should this happen before 100 days post transplant or even during conditioning

•Centres entering data directly can register the transplant on day 0, adding the necessary data after 100 days post HSCT.

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Which forms should be completed?

• The HSCT MED-A form contains the Minimum Essential Data that must be registered for every transplant

• It is divided into a Registration form, a series of Disease classification sheets, an Appendix and a Follow up Form

No items can be left blank or unknown unless specifically stated in the definition

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Which forms should be completed? (1) MED-A


Which forms should be completed? (2)MED-A: First report – 100 days after HSCT

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Which forms should be completed? (3)MED-A: First report – 100 days after HSCT - Donor

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• The disease specific Med-B form• The allograft or autograft specific MED-B

form • The combination of the above two forms

contain the Minimum Essential Data that must be registered for every transplant

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Which forms should be completed? (1) MED-B


Which forms should be completed? (2) MED-B: First report – 100 days after HSCT

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What the FU MED-AB form looks like

•Every year for transplants performed less than 10 years ago

•Every 2 years for transplants performed between 10 and 20 years ago

•Every 5 years for transplants performed more than 20 years ago

•At time of death

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Which forms should be completed? (1) MED-A: Follow up

The European Group for Blood and Marrow Transplantation The European Group for Blood and Marrow Transplantationwww.ebmt.org18

Which forms should be completed? (2) MED-A: Donor Cell Infusion form

Up to 4 Donor Cell Infusions given in the follow up period can be reported on this form

Make as many copies as necessary


•Every year for transplants performed less than 10 years ago

•Every 2 years for transplants performed between 10 and 20 years ago

•Every 5 years for transplants performed more than 20 years ago

•At time of death


MED-B: Follow up

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Which forms should be completed?MED-A: Cell Therapy form


A document called “MED-AB forms manual” is available in the Registry section of the EBMT website

It contains information on the forms, how to fill them in and where to send them once they have been completed

Questions must be read carefully before completing

If doubts appear as how to complete any forms, they should be addressed to the national registry or EBMT offices, which will ensure expert advice is sought in each case

The MED-AB manual

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... Data-Management/Registrystructure/MED-ABdatacollectionforms/Documents/MED-ABFormsManual.pdf


The UIC of the patient is a combination of two numbers: the CIC of the centre that performed the first HSCT of that patient, and a unique Patient number assigned to that patient

The Patient number forms part of the UIC, it is a unique database key, and should never be changed

All data for a patient should be entered under one UIC number, including subsequent transplants

Patients transferred to other centres for further transplants must always keep their original UIC number

Unique Identification Code (UIC)

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Previous SCT in other centre

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ProMISe users:

If your patient had a prior transplant elsewhere,use this form to request access to their existing UIC from the Registry office or National Registry

... Data-Management/Datasubmission/Documents/PatientGivenPreviousHSCTinOtherCentre.pdf


Patient consent & EU regulations

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In case the patient does not consent for his/her data to be transmitted to the EBMT, please provide –for auditing and accreditation purposes-:

- Diagnosis- Date of HSCT- Type of HSCT- Chronological number of HSCT

Consent to transfer data outside the European Economic Area must be explicitly obtained if the centre requests the EBMT to transfer data to institutions not located in this area.

...Data-Management/Dataconfidentiality/Documents/EuropeanUnionRegulationsOnDataProtection.pdf


Study Information

Patient following national / international study / trial: Yes No Unknown

Name of study / trial ......................................

Study / Trial• Indicate whether the patient has been included in a prospective

national/ international study/trial. If yes; enter the name of study/trial

• This should not be used for retrospective studies

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Patient Identification

PATIENT IDENTIFICATION

Unique Patient Number or Code: .................................. Compulsory, registrations will not be accepted without this item Initials: ............._.............. (first name(s) _family name(s)) Date of Birth: ............ - ............ - ............

yyyy mm dd Sex: Male Female

• Unique patient number (UPN): number/code used by the transplant centre to uniquely identify this patient. This item is compulsory. It must be unique and be able to identify the patient, it should not be liable to change.

If a patient receives a second transplant, do not assign a new number but always use the same unique number.

• Initials: initial of the first name of the patient followed by the initial of the surname of the patient.

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Primary Disease Diagnosis (1)

DISEASEDate of initial diagnosis: ............ - ............ - ........

yyyy mm ddComplete and attach the relevant Disease classification sheetwith date of HSCT and disease status at HSCT

• Date of diagnosis of the disease for which the patient is being grafted. • If the disease is of secondary origin, write the date of diagnosis of the

secondary disease, not the date of diagnosis of the original disease Important: an acute leukaemia preceded by a myelodisplastic or myeloproliferative syndrome is not a secondary disease, but rather a final stage of the myeloid syndrome

• If there is a concurrent disease (autoimmune disease, for example) for which the transplant is also indicated, add another date of diagnosis and the corresponding disease classification sheet

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http://www.ebmt.org/Contents/Data-Management/Registrystructure/MED-ABdatacollectionforms/Documents/DISMCLFD.pdf

Primary Disease Diagnosis (2)


Primary Disease Diagnosis (3): AML

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For MDS, we require the classification at diagnosis and at HSCT. If at date of HSCT there has been a transformation into Acute Leukaemia, the date of the transformation is also asked.

Primary Disease Diagnosis (4): MDS

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Primary Disease Diagnosis (5):

Autoimmune disease

Autoimmune disease: The type, involvement and antibodies studiedat time of HSCTare required

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Date of Haematopoietic Stem Cell Transplantation:• Day 0 is considered the day of the first haematopoietic stem

cell infusion if there are multiple infusions of one or several graft products over several days after the same preparative regimen.

Date of this HSCT: ...... - ........... - ........... yyyy mm dd

HSCT date

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• The disease status just before the preparative regimen should be assessed and reported here. This has to be done even if the patient’s disease status was assessed at mobilisation or collection in the autograft setting. The disease at stem cell collection and at transplantation may not be the same since the disease may have changed in the interval.

• For leukaemias, cytogenetic/molecular remission at HSCT should be evaluated: indicate if molecular marker or cytogenetic abnormality detected at diagnosis is still present at HSCT

Status at HSCT: Status at HSCT: Number For complete remission only, type of remission Primary induction failure (complete only for CR or relapse) No Yes Not eval. Unknown Complete haematological remission (CR) 1st Cytogenetic Relapse 2nd Molecular Never treated 3rd or higher

Status at HSCTStatus at HSCT (1)

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Check the definition of the status for each disease in the MED-AB manual The number of the status should be filled in

For lymphoma and solid tumours, PR after relapse is known as « sensitive relapse »

Status at HSCT (2)

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Performance

HSCTPerformance score System KarnofskyScore: Lansky 10 20 30 40 50 60 70 80 90 100

The Karnofsky and Lansky are standard performance scales, which inform about the physical status of the patient. Karnofsky is used for adults and Lansky for children.Refer to the Appendix I of the MED-AB manual to see the details of the scale

Do not forget to indicate the type of score used even if it seems obvious to you

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HSCT

HSCTType of HSCT: Autologous Allogeneic

• Autologous: the patient receives his/her own stem cells back

• Allogeneic: the patient receives stem cells from another person

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CMV status

HSCTPatient CMV status Negative Positive(for allografts) Not evaluated unknown

Serologic status :Enter the CMV (cytomegalovirus) status at transplant

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Multiple donors/products

Multiple donors/products No Yes: Number………(including multiple CB units or multiple stem cell products for same donor) …If allograft, replicate and fill this [Donor] box for each donor or different stem cell products of same donor

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• Enter whether the patient has received stem cell infusions from multiple donors or products and fill in the appropriate number, if applicable.

• Two cords are multiple donors• Two different products of the same donor are

multiple products

If there are multiple donors or products, please make copies of the donor section


Related Donor

DONORDonor ID…. …. …. …. ….HLA match type Syngeneic (monozygotic twin) HLA-identical sibling (may include non-monozygotic twin) HLA-matched other relative HLA-mismatched relative:

Degree of allele mismatch 1 HLA antigen mismatch > 2 HLA antigen mismatch

Donor ID: identification number of the donor Donor type: related• Syngeneic: the donor is a monozygotic twin (single egg)• HLA-identical sibling: the donor is a brother or sister with fully compatible

antigens• HLA-matched other relative: other family members (parents, cousins etc) HLA-

identical to the patient • HLA-mismatched related: family member but with different HLA antigens.

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Unrelated donor Name of donor registry/CB Bank.......... .......... .......... BMDW/WMDA code (up to 4 characters)…. …. …. …. ….

Unrelated Donor (1)

Donor type: unrelated• When there is no compatible donor in the family, a donor can be

found in donor registries or cord blood banks • BMDW/WMDA code: code given by the BMDW to the donor registry

or cord blood bank where the graft was found. http://www.bmdw.org/index.php?id=addresses_members&no

This may not be available so always enter the name of the donor registry or cord blood bank.

• important information on this unrelated donor will be the HLA compatibility with the patient, which will be derived from the HLA results reported

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http://www.bmdw.org/index.php?id=addresses_members&no

http://www.bmdw.org/index.php?id=addresses_members&no


Unrelated Donor (2)

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If you don’t send the HLA typing form with the initial MED-AB but later on, or if you register the MED-AB using ProMISe and want to forward the HLA typing form to the EBMT Registry or national registry, please use this cover page with the HLA results to ensure patient and donor can be easily identified by the EBMT.

Do not forget to add the donor ID


Donor Sex Male FemaleDonor CMV status Negative Positive

Not evaluated unknown

Donor

• Sex of the donor, which you may find in the histocompatibility forms, is important in relation to GvHD (graft versus host disease)

• Serologic status of the donor: please tick the CMV status

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Source of stem cells

Source of Stem Cells (check all that apply): Bone Marrow Peripheral Blood

Cord Blood Other: ............................

• Bone marrow (BM)• Peripheral Blood (PB)• BM + PBSC

• Cord Blood (CB)• CB + PBSC

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Chronological number of HSCT

Chronological no. of HSCT for this patient ..... Date of most recent previous HSCT: ......... - ..........- .......... yyyy mm ddType of most recent previous HSCT Allo Auto N/A

• Chronological number of this transplant: This item is very important. It refers to the number of the transplant, whether allogeneic or autologous, that this patient has received throughout his/her lifetime, regardless of whether previous transplants have been performed in your centre or in other centres.

• If this is a subsequent transplant, enter the date and type of the previous HSCT.

• If in another centre, you still need to specify the above. If not known exactly, indicate an approximate date (at least year and month)

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Multiple graft protocol

Sometimes patients are entered into protocols which include more than one transplant.

• Planned sequential protocol: Treatment by which the patient is subjected to n (up to 3 - 4) transplants, separated by an interval of no more than 6 weeks, all preceded by high dose chemotherapy

• Pre-planned double or triple transplant: Treatment by which the patient is subjected to 2 or 3

transplants. These transplants can be autologous or allogeneic or a combination. The sequence of transplants must have been decided prior to treatment and the interval between transplants can be as long as one year.

HSCT part of a planned multiple graft protocol? No Yes

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Graft manipulation

Graft manipulation ex-vivo (including T-cell depletion)(other than for RBC removal or volume reduction) No Yes

Ex-vivo (same as in-vitro) manipulation, including purging in autografts means “treatment of the graft in the laboratory”. There are two main categories

• For autografts, to reduce the risk of re-infusing tumour cells back into the patient, the collected material is manipulated ex-vivo in an attempt to remove tumour cells

• For allografts, T-cell depletion of the collected material is frequently used to reduce the probability of rejection and decrease the GvHD toxicity

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Preparative (conditioning) regimen (1)

Preparative (conditioning) regimen given? No (Usually Paed Inherited Disorders only) continue to page 2 Yes

Preparative regimen is the treatment administered to the patient before the transplant in order to eliminate malignant cells and improve the engraftment of the stem cells reinfusion

• All autografts get conditioning with chemotherapy with or without TBI

• Most allografts get conditioning with chemotherapy with or without TBI except for some inborn errors or retransplant for graft failure

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Was this intended to be myeloablative? (allo only) Yes No: Reason:

Age of recipient Comorbid conditions Prior HSCT Protocol driven Other, specify .......... .................

• Myeloablative= standard intensity• Non-myeloablative= must be reduced intensity = “mini transplant”:

-> Any regimen with 50% or less equivalence to a standard conditioning regimen is considered reduced intensity. This includes not only the 50% reduction of the total dose of a given drug (or TBI), but also the use of a single drug in a standard dose but without other drugs (or TBI) usually included in the standard protocol

• If non-myeloablative: give reason• Only used for allografts

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• Provide data for all drugs that apply

• Be careful with drug trade names: Cytosar=AraCCytoxan=Cyclophosphamide…

• Additional data required: Route of administration of

Busulfan Animal origin of ATG/ALG


• Drugs (alternative names, standard doses)

• Protocol description

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Preparative (conditioning) regimen (4)... Data-Management/Registrystructure/MED-ABdatacollectionforms/Documents/MEDAB0084.pdf


Preparative (conditioning) regimen (5) How should doses be reported?

Specification and dose of the preparative regimenDrug Total prescribed cumulative dose as per protocol (all agents given (= daily dose in mg/kg or mg/m² by nb of days; before day 0) eg. Busulfan given 4mg/kg daily for 4 days, total dose to report is 16mg/kg)

Busulfan 800 mg mg/m2 mg/Kg

Oral IV Both

Busulfan 16 mg/m2 mg/Kg

Oral IV Both

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Is it a standard or reduced dose?

no weight reported!

we don’t know if standard/ reduced

no weight needed!

we know it is standard


Total Body Irradiation

Total prescribed radiation dose as per protocolTotal Body Irradiation No Yes:.......... ......... Gy

TLI, TNI, TAI No Yes:.......... ......... Gy(lymphoid, nodal, abdominal)

TBI• External radiation sources that produce penetrating rays of energy to

deliver a relatively uniform amount of radiation to the whole body without damaging the overlying skin and surrounding tissue at risk

• Report the total dose (Gy); 2 days of 6Gy each total dose is 12Gy

TLI, TNI, TAI • Lymphoid, nodal or abdominal: sometimes used to further

immunosuppress the patient in order to facilitate engraftment. Fields of irradiation include most sites of lymphoid tissue, such as spleen, liver and lymph nodes above and below the diaphragm.

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After HSCT: GvHD prophylaxis

AFTER HSCTGvHD prophylaxis given (Allografts only)

No Yes: Immunosuppressive chemotherapy

ALG, ALS, ATG, ATS (given after day 0)

Anti CD25 (MoAB in vivo)

Campath (MoAB in vivo; can be "in the bag")

Corticosteroids Cyclosporine

Etanercept (MoAB in vivo)

FK 506 (Tacrolimus, Prograf) Infliximab (MoAB in vivo)

Methotrexate Mycophenolate (MMF) Sirolimus Other monoclonal antibody (in vivo),

specify .................................. Other agent (in vivo), specify........................

Extracorporeal photopheresis (ECP) Other, specify .................................

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Cell count recovery (engraftment)

Absolute neutrophil count (ANC) recovery (engraftment)(Neutrophils >0.5X109 /L) No: Date of last assessment: ........... - ........... - ...........

yyyy mm ddYes: Date of ANC recovery: ........... - ........... - ........

yyyy mm dd Lost graft Never below Unknown

• No recovery: neutrophils never reach 0.5 x 109/L. • Recovery: the number of neutrophils in the patient’s peripheral blood

rises above 0.5 x 106/litre before any additional treatment • Date of recovery: first of 3 consecutive days in which the number of

cells has reached the limit described below for each cell type.• Lost graft: neutrophils increase to 0.5 x 109/L for at least two

consecutive days and subsequently decrease to a low level until additional treatment to obtain engraftment is given.

• Never below: neutrophils never went below 0.5 x 109/L

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Acute Graft versus Host Disease

Acute Graft versus Host Disease (Allografts only) Maximum Grade:

0 (none) I II III IV Present but grade unknown Not applicable

Acute graft versus host disease (aGvHD)• aGvHD is a consequence of donor T-cells recognizing the patient’s

antigens as foreign. It usually consists of dermatitis, hepatitis and gastroenteritis.

• The maximum grade for acute graft versus host disease is defined according to the stage presented by the skin, liver and gut.

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ADDITIONAL TREATMENT INCLUDING CELL INFUSIONCell infusion (CI) (not HSCT or autologous stem cell re-infusion) No Yes Date of first infusion: . .......... ............ ........... (can be the same as HSCT date) yyyy mm dd

Type of cell(s): (check all that apply) Lymphocyte Mesenchymal Fibroblasts Dendritic cells Other, specify ............... ...............

Chronological no. of CI for this patient ..... Indication: (check all that apply) Planned/protocol Treatment for disease Prophylactic Mixed chimaerism Treatment of GvHD Treatment viral infection Loss/decreased chimaerism Treatment PTLD, EBV lymphoma Other, specify .........................

Number of infusions within 10 weeks ............ (count only infusions that are part of same regimen and given for the same indication)

Additional DCI (1)

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Additional DCI (2)

Aims: Graft enhancement, infection or disease prevention or treatment

Cell infusion after HSCT is usually donor lymphocyte infusion (DLI),but it can also be fibroblasts, mesenchymal or dendritic cells

• Date of the first infusion: can be the same as the date of HSCT

• Indication: Planned/protocol should be used when this DCI forms part of the overall protocol including HSCT and had been decided upon before the HSCT. All other reasons refer to decisions made a posteriori after assessing the patient after the transplant.

• Number of infusions within 10 weeks: DCI is often given as sequential cell infusions through a series of days or even weeks. One episode of cell infusion treatment is defined as any number of cell infusions that take place for the same indication within 10 weeks from first to last infusion

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Additional disease treatment

Disease treatment (apart from cell infusion)

No Yes: Planned (planned before HSCT)

Not planned (for relapse/progression or persistent disease)

Planned decision to give this treatment was made before the HSCT was performed

– Maintenance chemotherapy – Immunosuppressive treatment– Growth factors

Not planned decision to give this treatment was made after the HSCT was performed

• Chemotherapy given for relapse/persistent disease, treatment of infection or disease (GvHD), graft failure

• Subsequent transplant (please complete a new transplant form)• Autologous BM or PBSC Re-infusion: the patient received an infusion of

autologous stem cells (a top-up) after graft failure (This is not considered a transplant; you do not have to complete a new form)

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Best response

DISEASE STATUS Best disease status (response) after HSCT(prior to treatment modification in response to a post HSCT disease assessment) Continued complete remission (CR) CR achieved: Date achieved : …....... - …....... - ...........

yyyy mm dd

Never in CR: Date assessed: .......... - .......... - .......... Not evaluated yyyy mm dd

• For most diseases, the best response is measured approximately at 100 days after HSCT

• For some diseases (PCD, CL), response may take much longer to stabilize• Indicate if the patient is in complete remission or not

If the patient was in CR before HSCT and is still in CR, tick Continued complete remission

If CR was achieved after the HSCT, enter the date it was achieved• If the patient is not in CR, enter the last date the patient’s disease status was

recorded• If the patient dies soon after HSCT, the disease could be “not evaluated”

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Date of last contact

DATE OF LAST CONTACT

Date of last follow up or death: ........ - ........ - ........ yyyy mm dd

• If the patient has not died, enter here the date the patient was last known to be alive -leaving the hospital or coming back for a visit- and not the date the form was filled out.

• If the first registration is done more than 3 months after HSCT, always use the latest possible date for reference, even if you are using the "100 days after HSCT" form.

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First relapse / progression (1)

FIRST RELAPSE OR PROGRESSION First Relapse or Progression after HSCT (Any method)

No: Date assessed ........... - ........... - ........... yyyy mm dd

Yes: Date first seen ........... - ........... - ...........yyyy mm dd

Continuous progression since HSCT

Fill in only for acute and chronic LEUKAEMIAS If yes or continuous progression , tick all methods used for assessment with dates on which they were used and the results.

Relapse/progression detected by clinical/haematological method: No: Date assessed ........... - ........... - ...........

yyyy mm dd Yes: Date first seen ........... - ........... - ...........

Not evaluated yyyy mm dd

Relapse/progression detected by cytogenetic method: No: Date assessed ........... - ........... - ...........



Relapse/progression detected by molecular method: No: Date assessed ........... - ........... - ...........



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First relapse / progression (2)

For all diseases, a relapse or progression indicates that there is a return of the original disease or an increase in disease burden, clearly progressing as compared to the state of the disease prior to transplant.

• If the patient has relapsed or progressed after transplant enter ‘yes’. Fill in the rest of this section if the diagnosis is leukaemia

• If the patient was already in progression before HSCT and has not managed to improve, the answer is Continuous progression

• Haematological relapse: see definitions for each diagnosis. Indicate the first date it was noted

• Cytogenetic/Molecular relapse: reappearance of chromosome abnormality/molecular markers detected earlier in the history of the disease.

• Cytogenetic/molecular relapse can only be determined if cytogenetic/molecular remission has been previously demonstrated

• Indicate the first date it was noted; this may be different from the date of haematological relapse.

• Always enter the last date assessed, if patient did not relapse or progress. This may be different from the last date the patient was seen (date of last contact).

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Last disease assessment (1)

DISEASE PRESENCE/DETECTION AT LAST CONTACTLast disease status (record the most recent status and date for each method, depending on the disease)

Was disease detected by clinical/haematological method? No Yes Last date assessed ........... - ........... - ...........


Fill in only for acute and chronic LEUKAEMIASWas disease detected by cytogenetic/FISH method?:

No Yes:Considered disease relapse/progression: No Yes Last date assessed ........... - ........... - ...........


Fill in only for acute and chronic LEUKAEMIASWas disease detected by molecular method?:

No Yes: Considered disease relapse/progression No YesLast date assessed ........... - ........... - ...........


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Last disease assessment (2)

The last evaluation of the haematological/clinical disease presence must be indicated hereDisease detected by cytogenetic/molecular method, for leukaemias only : if a cytogenetic abnormality/molecular marker was detected before the HSCT, we need to know if it is still present after the HSCTIf no cytogenetic abnormality/molecular marker was detected before the HSCT, this is not applicable

• A patient may have relapsed after the last HSCT but be in CR –so no disease presence detected- at last contact if they have received a new non HSCT treatment in between.

• The opposite is also true, the patient may not have progressed but because CR was never achieved after transplant, there may be disease presence detected at last contact.

For non malignant diseases, this question may be irrelevant

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Survival status

PATIENT STATUS AT LAST CONTACT

Survival Status: Alive Dead Died before HSCTCheck here if patient lost to follow up

Survival status• Tick Died before HSCT in case the patient dies during or after the

preparative regimen but before the cell infusion• It is important to know the status of the patient as survival is the

most significant outcome for most diseases• If the patient is lost to follow up, you can check it here. For

patients lost to follow up, the date of last contact is the last date the patient was known to be alive

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Main cause of death

PATIENT STATUS AT LAST CONTACTMain Cause of Death (check only one main cause): Relapse or Progression/Persistent disease HSCT Related Cause

(check as many as appropriate): GVHD Cardiac Toxicity

Rejection/Poor graft function Infection Pulmonary toxicity Veno occlusive disorder Other (related):.......................................................…...

Unknown Other (not related): .....................................................................

Tick only one of the 3 major causes of death:• Relapse/progression• HSCT related cause

and check as many causes as are considered to have been contributory to the outcome

• Other non HSCT related cause

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Complications post transplant (1): Late graft failure (allografts)

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COMPLICATIONS OF TRANSPLANTLate graft failure No Yes

There is no time limit to request this information


Complications post transplant (2): Chronic GvHD (allografts)

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Chronic Graft Versus Host Disease present during this period (allografts only) No (never)

Yes: First episode since last HSCTDate of diagnosis of cGvHD:

........... - ........... -..........yyyy mm dd

RecurrenceDate first evidence of cGvHD during this period:

........... - ........... -..........yyyy mm dd

Continuous since last reported episode

Maximum extent during this period Limited Extensive Unknown

Resolved since last report (currently absent)

There is no time limit to request this information


Complications post transplant (2)

Graft versus host disease

Please check the previous follow-up form and either mark; – ‘no’ (never)– ‘yes’ and either ‘first episode’ plus date of diagnosis or

‘recurrence’ plus date of recurrence, or Continuous from previous episode. There may be several successive episodes

– If yes, please mark the grade; ‘limited’ or ‘extensive’. cGvHD is considered limited if it is present only in the liver, the

skin or both If the cGvHD affects any other organ(s), it is considered to be

extensive. Tick only one box. – cGvHD resolution: if previous GvHD has been resolved, tick here.

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Complications post transplant (3): Chronic GvHD (allografts)


Complications post transplant (3)

Did a secondary malignancy, lymphoproliferative or myeloproliferative disorder occur?

No Yes: Date of diagnosis: ........... - ........... - ........... yyyy mm dd Diagnosis: ......................................................

• Patients can develop secondary disorders like MDS, acute leukaemia or lymphoproliferative disorders. If this is the case, tick "Yes", provide date of diagnosis and indicate which diagnosis

• This must be a disease for which the patient had not been diagnosed before the transplant.

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Complications post transplant (4): Secondary malignancy


Additional treatment

ADDITIONAL TREATMENT No Yes: Date ........... - ........... - ...........

yyyy mm dd

If yes: Additional cell infusion No Yes: Attach the CI sheet completing

as many sections as necessary Other disease treatment No Yes: Planned (planned before transplant)

Not planned (for relapse/progression or persistent disease)

As in first report, report here:• any cell therapy, please attach the CI (cell infusion) sheet• disease treatment either planned (maintenance, etc.) or

unplanned (relapse, infection treatment, etc.)

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Conception

CONCEPTION Has patient or partner become pregnant after this transplant?

Yes No Unknown

• Indicate whether a female patient or the partner of a male patient has become pregnant since the patient underwent the transplant procedure.

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• Inconsistency checks: QP2 module (see slide 78), JACIE and inspection, registry studies

• Sensitive items: dates, drugs, HLA, disease status

Check regularly the last version of the MED-AB forms, and refer to the manual as much as possible (If you or doctors from your unit disagree on the definitions, bring it to the attention of the Working Parties)

• Our aim is to collect good data:1. For regulatory issues 2. For representative and valid studies 3. To avoid spending your time and our time checking

inconsistent data once the data is already in the database

4. To improve the outcome of patients

Recommendations for a better data quality (1)

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• Submit data regularly:– Register the transplants as they take place, at day 100 or at day 0. Do not leave

them all to the last minute at the end of the year

– Add a follow up every year, on the date it is due. If you use ProMISe, help yourself by using the existing follow up due reports. You can have them automatically e-mailed to you every month

• If you are catching up and the last follow up dates back several years, complete one follow up only. The form is designed in such a way that you will still be able to report all events that occurred during the patient’s post-transplant period regardless of the timing

• If you complete the MED-B, you don’t need to do the MED-A

• Update ALL your transplants as per the formula described in previous slide


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• If the answer to the question is “No”, “Not applicable” or “Not evaluated”, do tick the corresponding boxes. Do not leave blanks, blanks do not mean anything.

• Avoid using the code “Other”: if you can’t find the proper code in the database, ask for help. It takes a long time to check and recode all these “other” data.

• Do not write lengthy comments. These cannot be used in analysis. Comments should only be written when the situation is truly difficult to code, that is, very rarely.

• If the information requested in the MED-AB paper forms is unavailable, this must be clearly stated, thus preventing the EBMT or national registry managers from requesting the data again.

• If you do not know how and where to find the information

Please ASK!!


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For information on submitting data directly to the EBMT Registry database using ProMISe, please refer to:

.../Data-Management/Registrystructure/DatamanagementsystemProMIse/Pages/Data-management-system-ProMIse.aspx

– Internet based data entry system– Entry to system via password– Centre can enter their own data– Correction of existing data– Allows downloading of data for analysis

The Registry Database

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Tools (1): EBMT website: www.ebmt.org

Direct access to:

• MED-AB forms • Manuals• Guidelines on data

submission• Report information• Help documents• Helpdesk• ProMISe login

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Export MED-A data from ProMISe and merge it in a Word document or Excel spreadsheet in order to get a pre-filled MED-A:

Missing data can be highlighted (used by the Registry Office; you can use it to find out your own missing data)

Missing data is not highlighted (printing of MED-A forms; useful for JACIE, for example, or to store with patient’s notes)

You can download it from:...Data-Management/Dataretrieval/Pages/Data-retrieval.aspx

Please contact us if you need more [email protected]

Tools (2): QueriesP2 module

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Documentation (1): Registry useful information

For downloads of the MED-AB forms and help files on clinical content

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Documentation (2): The MED-AB data collection forms

•MED-A•MED-B:

– Allograft/Autograft– Disease

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•Data submission and the Med-A

•MED-AB manual•Disease classifications•List of drugs & protocols•Disease status and

response

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Documentation (3): MED-AB Manuals


Documentation (4): Cell therapy data collection form and manual

•Cell therapy MED-A and manual

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[email protected]