NCT04822766Active, not recruiting
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 · Last updated 13 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 24 Jan 2021
- Start date
- Dec 2021
- Primary completion date
- Jun 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT04822766
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From Dec 2021 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- HIV positive patient
- Severe neurological disorders
- Patient with severe psychiatric disorders or hospitalized without consent for psychiatric care
Lab values
- Acute or chronic heart failure (Cardiac ejection fraction \< 40%)
Other
- Acute promyelocytic leukemia (AML FAB M3)
- AML deemed not eligible for allo-HSCT
- Karnofsky score \<70%
- Life expectancy less than one month according to the attending physician
- Pulmonary function - diffusion capacity \< 50% predicted
- Estimated glomerular filtration rate \< 50 ml/min (CKD-EPI)
- 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
Who the study is looking for
- 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
Age in the registry: 65 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saint Antoine Hospital - Hematology Department Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.