Clinical trial · Interventional
A Study Comparing Allogeneic Hematopoietic Cell Transplantation Versus Best Available Standard of Care Therapy in Elderly Patients With Acute Myeloid Leukemia
Allogeneic Hematopoietic Cell Transplantation Versus Best Available Standard of Care Therapy in Elderly Patients With Acute Myeloid Leukemia: a Randomized Phase 3 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A subject of major interest for researchers, clinicians, patients, and payers, is the role of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the treatment of these older patients with AML. With conventional induction chemotherapy or hypomethylating agents, the expected 2-year overall survival (OS) is less than 25% in patients with intermediate- or high-risk disease. The 2-year OS ranges from 50 to 56% with allo-HSCT in AML patients older than 65 years. Performing an allo-HSCT in older patients is however still controversial because of the higher risk of non-relapse mortality (15 to 35%) and graft-versus-host disease. Depending on the center policy, patients older than 65 years will either be contraindicated for transplant or will receive allo-HSCT. With a phase III comparative, randomized, controlled, prospective, multicenter study, the trial aim to assess prospectively the outcomes and quality of life of older patients with AML receiving allo-HSCT strategy compared to those receiving a non-transplant approach.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best chemotherapy treatment | Drug | — | UNRESOLVED |
| Hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- interventionNames
- Drug: Best chemotherapy treatment
- type
- EXPERIMENTAL
- label
- Allogeneic Hematopoietic Cell Transplantation
- description
- Time of transplant procedure The best available treatments of AML
- interventionNames
- Procedure: Hematopoietic stem cell transplantation
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 2 years after the inclusion
- description
- From inclusion (time of identification of potential donor) until death or at 24 months, whichever comes first\]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women * Age ≥ 65 and ≤ 75 years * Newly diagnosed patients with de novo or secondary AML in first complete remission who are considered as potential candidates and eligible for an allo-HSCT procedure * Presence of a donor (matched related or unrelated or haplo-mismatched) willing to donate peripheral blood stem cells * Patient is fit for the allo-HSCT procedure * Patient is fit for further consolidation therapy (non-transplant arm) * Written informed consent Exclusion Criteria: * Acute promyelocytic leukemia (AML FAB M3) * AML deemed not eligible for allo-HSCT * Karnofsky score \<70% * HIV positive patient * Life expectancy less than one month according to the attending physician * Acute or chronic heart failure (Cardiac ejection fraction \< 40%) * Pulmonary function - diffusion capacity \< 50% predicted * Estimated glomerular filtration rate \< 50 ml/min (CKD-EPI) * Severe neurological disorders * Patient subject to a legal protection measure (guardianship, curatorship and safeguard of justice) or unable to consent * Patient deprived of their liberty by a judicial or administrative decision * Patient with severe psychiatric disorders or hospitalized without consent for psychiatric care
References
Publications (0)
Data not yet available