Acute Myeloid Leukemia
Conditions
Brief summary
Group A1-A3: The primary endpoint is Event Free Survival (EFS), Group B: The primary endpoint is Overall Survival (OS). OS is defined as the time from inclusion to death from any cause. Survivors will be censored at the date of the last follow-up evaluation, Group C: A composite endpoint will be used as primary endpoint. Graft-versus host disease, VOD, Relapse Free Survival (GVRDS) is defined as the time from randomization to first failure event.
Detailed description
Group A, C: Overall survival (OS), Group B, C: Event Free Survival (EFS), All Groups: Cumulative incidence of Relapse (CIR), All Groups: Non-relapse mortality (NRM), Group A: Primary induction failures, Group A: Risk-Group after Induction 2 Disease-free survival (DFS), Group A: Blast at Ind1, Group A: MRD-level at Ind1, Group A: MRD-level at Ind2, Group A-C: Adverse Events, Group A-C: Early death Complete remission (CR), Group A-C: CNS infestation (CICNS), Group C: Graft failure, Group C: Engraftment, Group C: aGvHD, Group C: cGvHD, Group C: VOD Grade 3/4
Interventions
DRUGCYTARABINE
DRUGCYCLOPHOSPHAMIDE
DRUGMETHOTREXATE
DRUGMITOXANTRONE HYDROCHLORIDE
DRUGETOPOSIDE
DRUGMELPHALAN
DRUGBUSULFAN
DRUGFLUDARABINE
DRUGGEMTUZUMAB OZOGAMICIN
DRUGPREDNISOLONE
DRUGTHIOTEPA
DRUGTREOSULFAN
Sponsors
GPOH gGmbH
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group A1-A3: The primary endpoint is Event Free Survival (EFS), Group B: The primary endpoint is Overall Survival (OS). OS is defined as the time from inclusion to death from any cause. Survivors will be censored at the date of the last follow-up evaluation, Group C: A composite endpoint will be used as primary endpoint. Graft-versus host disease, VOD, Relapse Free Survival (GVRDS) is defined as the time from randomization to first failure event. | — |
Secondary
| Measure | Time frame |
|---|---|
| Group A, C: Overall survival (OS), Group B, C: Event Free Survival (EFS), All Groups: Cumulative incidence of Relapse (CIR), All Groups: Non-relapse mortality (NRM), Group A: Primary induction failures, Group A: Risk-Group after Induction 2 Disease-free survival (DFS), Group A: Blast at Ind1, Group A: MRD-level at Ind1, Group A: MRD-level at Ind2, Group A-C: Adverse Events, Group A-C: Early death Complete remission (CR), Group A-C: CNS infestation (CICNS), Group C: Graft failure, Group C: Engraftment, Group C: aGvHD, Group C: cGvHD, Group C: VOD Grade 3/4 | — |
Countries
Austria, Czechia, Germany, Greece, Italy, Poland
Outcome results
None listed