Using stem cell transplants for AML patients in first remission under 60 years old
Prospective Multicenter Randomized Controlled Clinical Trial for Evaluation the Role of Allo-HSCT in the First Complete Remission, MRD-negative After the First Course, in Patients With AML Under the Age of 60 Years
This study is testing if stem cell transplants can help younger patients with acute myeloid leukemia who are in their first remission live longer and healthier lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | National Research Center for Hematology, Russia Research network |
| Drugs / interventions | chemotherapy, Fludarabine |
| Locations | 1 site (Moscow) |
| Trial ID | NCT05339204 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with acute myeloid leukemia (AML) who are in their first complete remission and are under 60 years of age. Patients are categorized into three groups based on specific genetic markers and treatment regimens, including '7+3', 'FLAG', and maintenance therapies. The study aims to assess the minimal residual disease (MRD) status after initial treatments and determine the best subsequent treatment approach based on MRD negativity. The trial is designed to evaluate the potential benefits of allo-HSCT in improving long-term outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are newly diagnosed AML patients aged 18 to 59 years who have not received prior chemotherapy.
Not a fit: Patients with relapsed or refractory AML, or those with specific genetic abnormalities not included in the study, may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could significantly improve survival rates and quality of life for AML patients in their first remission.
How similar studies have performed: Previous studies have shown promising results with allo-HSCT in similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Newly diagnosed, previously untreated AML; 2. Age from 18 to 59 years; 3. Somatic status - ECOG \< 3. Exclusion Criteria: 1. previous chemotherapy for AML; 2. pregnancy; 3. relapses and refractory forms of AML; 4. acute promyelocytic leukemia; 5. blast crisis of chronic myeloid leukemia; 6. de novo AML with t(9;22); 7. AML transformed from MDS or MPN after treatment, for which a different protocol is provided; 8. Blastoid plasmacytoid dendritic cell neoplasia (with the exception of cases when a small population of plasmacytoid dendritic progenitors is detected in the leukemic neoplasia). 9. Undifferentiated acute leukemia
Where this trial is running
Moscow
- National Research Center for Hematology — Moscow, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Irina Lukianova, MD PhD
- Email: Irina.donskova99@mail.ru
- Phone: +79653493473
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.