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

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Criteria

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 < 30 ml/min (CKD-EPI)

• Severe neurological or psychiatric disorders Recruitment procedure