Acute Myeloid Leukaemia MedDRA version: 20.0 Level: PT Classification code 10000881 Term: Acute myeloid leukaemia (in remission) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Fludarabin
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: FLUDARABINE
CAS Number: 21679141
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Con
Sponsors
European Society for Blood and Marrow Transplantation EBMT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at registration: - Age >= 60years and 70 (see appendix of the trial protocol) - Written informed consent Inclusion criteria at randomization: - Patient is registered in this trial - Complete remission must be confirmed after first consolidation cycle according to the response criteria enlisted in the appendix of the trial protocol with the following exception regarding the peripheral blood recovery (B1): Peripheral Blood Recovery (PBR): ANC >=1.5x10^9/l or 1500/mm^3, transfusion independent platelet count >=50x10^9/l (i.e. 48 h after last transfusion) and no leukemic blasts in the peripheral blood and no dysplasia - AND platelet count must be increasing -Matching (10/10: HLA-A, -B, -C, DRB1 and DQ) related or unrelated donor is available Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria at registration - AML FAB M3 - HIV positivity Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if - The second study exclusively concerns induction therapy - Consolidation cycle one and two are given according to the accredited study group policy - No investigational drugs are used post registration for the HCT vs CT in eldery AML study. - Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted Exclusion criteria at randomization: - Organ dysfunction - Patients with creatinine clearance 2x the upper limit of normal, SGOT and SGPT - 4x the upper limit of normal - Patients with poorly controlled hypertension - Patient has undergone more than one consolidation cycle - More than 5 months (>150 days) after diagnosis - Participation in another clinical trial without prior consent of the coordinating investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate LFS after allogeneic HCT in AML/RAEB in CR using matched or unrelated donors in comparison to conventional chemotherapy Primary endpoints - Leukemia free survival (LFS) ;Secondary Objective: to evaluate overall survival, relapse, treatment related mortality and complications after HCT Secondary endpoints - Overall survival (median survival if possible; otherwise survival until 40% or 30% alive) - Incidence of relapse - Incidence of myelosuppression (ANC 2 days, platelets 2 days) after initial PBSC infusion - Incidence of grades 2-4 acute GvHD after transplant - Incidence of grades chronic extensive GvHD after DLI - Treatment related mortality (TRM) - Haematopoietic reconstruction (rejection / poor graft function, respectively) - Time course of blood parameter after transplant or conventional chemotherapy ;Primary end point(s): Leukaemia-free survival | — |
Countries
Austria, France, Germany, Netherlands
Outcome results
None listed