CIC: HSCT - Minimum Essential Data - A FOLLOW UP REPORT - ANNUAL Disease PRIMARY DISEASE DIAGNOSIS Centre Identification EBMT Code (CIC): Hospital: Contact person: Unit: Email: Patient Data Date of this report: Patient following national / international study / trial: Name of study / trial... Hospital Unique Patient Number/ Code: (Compulsory, registrations will not be accepted without this item) (first name(s) _family name(s)) Initials: _ Date of birth Male Sex Female (at birth) Date of the most recent transplant before this follow up: Date of Last Contact Date of last follow up or death: Best response after HSCT (CLL & Myeloma only) Best disease status (response) after transplant (prior to any treatment modification in response to a post HSCT disease assessment) Continued complete remission (CCR) CR achieved: Date achieved : Never in CR: : Previously reported Page 1
Secondary Malignancy Did a secondary malignancy, lymphoproliferative or myeloproliferative disorder occur? Additional Disease Treatment including Cell Therapy Was additional treatment given for the disease indication for transplant? -Cell therapy Start date of the additional treatment since last report Did the disease treatment include additional cell infusions : Chemo/drug Radiotherapy Is this cell infusion an allogeneic boost? (excluding a new HSCT) An allo boost is an infusion of cells from the same donor without conditioning, with no evidence of graft rejection. Is this cell infusion an autologous boost? If cell infusion is not a boost, please attach the Cell Infusion (CI) sheet on the last page, completing as many sections as episodes of cell infusion that took place during this interval, then continue below -Chemo / radiotherapy Additional disease treatment given excluding cell infusion? Date started Date of diagnosis: Diagnosis:... Is this secondary malignancy a donor cell leukaemia? t Applicable Imatinib mesylate (Gleevec, Glivec) Dasatinib (Sprycel) Nilotinib (Tasigna) Bortezomib (Velcade) Lenalidomide (Revlimid) Rituximab (Rituxan, mabthera) Velafermin (FGF) Kepivance (KGF, palifermin) Thalidomide Eculizumab (Soliris) Other drug/chemotherapy, specify... Relapse or Progression after HSCT First Relapse or Progression after HSCT (detected by any method) Continuous progression since HSCT Prophylaxis / preemptive/ preventive For relapse / progression or persistent disease Intrathecal: (planned before the transplant took place) (not planned) Tick here if continuous from last follow up report Page 2
Relapse of Leukaemias If or Continuous and diagnosis is acute or chronic leukaemia, fill in the section below: Method of detection of the first relapse or progression after HSCT Relapse/progression detected by clinical/haematological method: : t evaluated Relapse/progression detected by cytogenetic method: : t evaluated Relapse/progression detected by molecular method: : t evaluated Last disease status All diseases Disease status when the patient was last assessed? (or date of death) (record the most recent status and date for each method, depending on the disease) Was disease detected by clinical/haematological method when the patient was last assessed or date of death? t evaluated since HSCT was done Last disease assessment - Leukaemias Was disease detected by cytogenetic/fish method when the patient was last assessed or date of death? Was the presence of the disease considered relapse/progression since HSCT? t evaluated during this period Was disease detected by molecular method when the patient was last assessed or date of death? Was the presence of the disease considered relapse/progression since HSCT? t evaluated during this period Page 3
Pregnancy after HSCT Has patient or partner become pregnant after this transplant? Did the pregnancy result in a live birth? Survival Status Alive Dead Check here if patient lost to follow up Main Cause of Death Relapse or Progression/Persistent disease Secondary malignancy HSCT Related Cause Other Contributory Cause of Death (check as many as appropriate): GVHD Interstitial pneumonitis Pulmonary toxicity Infection: bacterial viral Fungal parasitic (check only one main cause) Rejection/Poor graft function History of severe Veno occlusive disorder (VOD) Haemorrhage Cardiac toxicity Central nervous system (CNS) toxicity Gastrointestinal (GI) toxicity Skin toxicity Renal failure Multiple organ failure Other: Page 4
CELL INFUSION (CI) SHEET HSCT - Minimum Essential Data - A FOLLOW UP REPORT - ANNUAL Date of first infusion: CELL INFUSION Disease status before this CI CR t in CR t evaluated Cell infusion (CI) regimen (not HSCT or autologous stem cell re-infusion) Source of cell(s): Allo Auto Type of cell(s): Lymphocyte (DLI) Mesenchymal Fibroblasts Dendritic cells NK cells Regulatory T-cells Gamma/delta cells Other, specify Chronological number of CI for this patient Indication: (check all that apply) Planned/protocol Loss/decreased chimaerism Treatment for disease Treatment viral infection Number of infusions within 10 weeks... Prophylactic Mixed chimaerism Treatment of agvhd Treatment of cgvhd Treatment PTLD, EBV lymphoma Other, specify: (count only infusions that are part of same regimen and given for the same indication) Acute Graft Versus Host Disease (after this infusion but before any further infusion / transplant): Maximum Grade: 0 (none) 1 2 3 4 Present but grade unknown Date of first infusion: Disease status before this CI Cell infusion (CI) regimen (not HSCT or autologous stem cell re-infusion) Source of cell(s): Allo Auto Type of cell(s): Lymphocyte NK cells (DLI) Chronological number of CI for this patient CELL INFUSION CR t in CR t evaluated Mesenchymal Fibroblasts Dendritic cells Regulatory T-cells Gamma/delta cells Other, specify Indication: (check all that apply) Planned Loss/decreased chimaerism Treatment for disease Treatment viral infection Number of infusions within 10 weeks... Prophylactic Mixed chimaerism Treatment of agvhd Treatment of cgvhd Treatment PTLD, EBV lymphoma Other, specify: (count only infusions that are part of same regimen and given for the same indication) Acute Graft Versus Host Disease (after this infusion but before any further infusion / transplant): Maximum Grade: 0 (none) 1 2 3 4 Present but grade unknown Page 5