Acute Myeloid Leukemia (AML) blood cancer
Conditions
Interventions
Randomisation between 2 conditioning regimens:
1) BuCyMel, standard arm
2) CloFluBu, experimental arm
Sponsors
Västra Götaland Regionen
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for randomization part of the study: • Age
Exclusion criteria
Exclusion criteria: Exclusion criteria for randomization part of the study: • Diagnosis of juvenile myelomonocytic leukemia (JMML). • History of previous malignancy (AML diagnosed as secondary cancer). • Known diagnosis of Fanconi anemia. • Prior autologous or allogeneic hematopoietic stem cell transplant. • Planned prophylactic DLI or other immunotherapeutic interventions after HCT that are not included in the upfront protocol, • Planned anti-leukemic medication after HCT that are not included in the upfront protocol • Known intolerance to any of the chemotherapeutic drugs in the protocol. • Major organ failure precluding administration of planned chemotherapy. • Patients with uncontrolled bacterial, viral, or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment. • Severe concomitant disease that does not allow treatment according to the protocol at the investigator*s discretion, e.g. malformation syndromes, cardiac malformations, metabolic disorders, renal impairment (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end-point is a comparison of the 2-year acute grade III to IV-free, chronic nonlimited GVHD-free, relapse-free survival (GRFS) between the 2 arms of the trial. GRFS is defined as the time from randomization to the first event (acute GvHD III-IV, chronic nonlimited GvHD, relapse, death) or last follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory endpoints in both interventional and observational parts of the study: - Disease free Survival (DFS) - Overall Survival (OS) - Cumulative incidence of relapse (CIR) - Transplant-related Mortality (TRM) - Hematologic Recovery - Graft Failure (GF) - Immunereconstitution - Acute GVHD - Chronic GVHD - Infections - Toxicity | — |
Countries
Netherlands
Outcome results
None listed