Comparing stem cell transplantation to standard therapy for older 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
NA · Assistance Publique - Hôpitaux de Paris · NCT04822766
This study is testing whether a stem cell transplant can help older patients with acute myeloid leukemia do better than the usual treatments they currently receive.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 65 Years to 75 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT04822766 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of allogeneic hematopoietic stem cell transplantation (allo-HSCT) with the best available standard care in elderly patients diagnosed with acute myeloid leukemia (AML). The study will enroll patients aged 65 to 75 who are newly diagnosed and considered potential candidates for allo-HSCT. By conducting a randomized, controlled, multicenter approach, the trial seeks to assess both the outcomes and quality of life for participants receiving either treatment. This is particularly important as previous studies have not adequately addressed this patient population's needs.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 65 to 75 years with newly diagnosed acute myeloid leukemia who are eligible for stem cell transplantation.
Not a fit: Patients with acute promyelocytic leukemia, those not eligible for allo-HSCT, or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve survival rates and quality of life for elderly patients with acute myeloid leukemia.
How similar studies have performed: While similar approaches have been attempted in the past, this study is novel as it specifically addresses the elderly population with AML and compares allo-HSCT to a non-transplant strategy.
Eligibility criteria
Show full inclusion / exclusion 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 \< 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
Where this trial is running
Paris
- Saint Antoine Hospital - Hematology Department — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Rémy DULERY, MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Rémy DULERY, MD
- Email: remy.dulery@aphp.fr
- Phone: 01 49 28 26 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myeloid Leukemia, Allogeneic, hematopoietic cell transplantation, acute myeloid leukemia