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Clinical Trials in France / NCT04822766
Active, not recruiting Not applicable

A Study Comparing Allogeneic Hematopoietic Cell Transplantation Versus Best Available Standard of Care Therapy in Elderly Patients With Acute Myeloid Leukemia

NCT04822766 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2021-12-31
Last updated
2025-08-13

Condition(s) studied

Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

Hematopoietic stem cell transplantationBest chemotherapy treatment

Hematopoietic stem cell transplantation: patients will undergo allo-HSCT after consolidation therapy (or completion of other appropriate non-palliative strategy) according to standard procedures of the transplant center (choice of donor, conditioning regimen, GVHD and infection prophylaxis). The use of novel therapies (such as sorafenib, midaustorine, venetoclax, etc.) will be allowed as post-transplantation maintenance strategy.

Best chemotherapy treatment: patients will be treated according to the standard procedures of the treating center for this type of population. Patients will receive the best available treatments (including additional conventional chemotherapy or other non-palliative therapies such as 5-azacytidine, decitabine, venetoclax, midaustorine, enasidenib, etc.).

Study summary

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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Overall survival — 2 years after the inclusion
    From inclusion (time of identification of potential donor) until death or at 24 months, whichever comes first\]

Trial sites (1)

FacilityCityRegionStatus
Saint Antoine Hospital - Hematology Department Paris France

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Other trials for the same condition

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IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04822766 on ClinicalTrials.gov ↗ ← All trials in France