FLUDARABINE-TREOSULFAN REDUCED INTENSITY CONDITIONING REGIMEN PRIOR HAPLOIDENTICAL STEM CELL TRANSPLANTATION WITH POST TRANSPLANTATION CYCLOPHOSPHAMIDE FOR OLDER AND/OR FRAIL PATIENTS WITH AML

Conditions

• Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• fludarabine and treosulfan — DRUG
  As per standard practices, patients will be hospitalized during the treatment period. The treatment is administered by the nurses of the department under the responsibility of the investigator.Fludarabine (30 mg/m²/day from day-6 to day-2), iv andTreosulfan (10 g/m²/day from day-4 to day-2), iv

Study Details

Acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) predominantly affect older adults, and their incidence continues to rise with advanced age. For many patients, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative option capable of providing long-term disease control through the graft-versus-leukemia (GVL) effect. Historically, however, allo-HSCT was rarely offered to patients older than 50 years because of the high morbidity and mortality associated with myeloablative conditioning regimens and limited supportive care strategies. Over the past two decades, advances in reduced-intensity conditioning (RIC), infection prophylaxis, and donor availability have profoundly transformed the landscape, allowing increasing numbers of older patients to access transplantation. Multiple studies have demonstrated that allo-HSCT confers a survival benefit in older AML patients in complete remission compared with consolidation chemotherapy alone. The intensity of conditioning profoundly influences both relapse risk and non-relapse mortality (NRM). myeloablative conditioning (NMAC) regimens are attractive for older adults due to their low toxicity but rely solely on the immunologic GVL effect and thus carry a higher relapse risk. Reduced-intensity conditioning (RIC) regimens, incorporating intermediate-dose alkylating agents such as busulfan, melphalan, or thiotepa, offer stronger anti-leukemic effect but at the cost of greater toxicity. These observations underscore the central question: can a conditioning regimen combine strong anti-leukemic potency with the low toxicity required for older patients undergoing Haplo-SCT? The main objective is to evaluate the efficacy of FT-RIC regimen before Haplo-SCT for older and/or frail patients diagnosed with AML, who are not eligible for a myeloablative conditioning (MAC) regimen. To achieve this objective, the investigators will assess Progression Free Survival (PFS) defined as the time from allo-HSCT to AML relapse or death. This is a Multicenter trial, single arm prospective of phase II. Once the conditioning has been administered and the transplant performed, the patient will receive standard routine follow-up care, with the addition of questionnaires, and for patients followed at the Institut Paoli Calmettes only, blood samples will be collected.

Key Dates

First listed

May 20, 2026

Start date

Oct 10, 2026

Status verified

May 2026

Primary completion

Oct 10, 2030

Completion

Feb 10, 2031

Study Design

Enrollment

77 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: fludarabine and treosulfan
  After screening and inclusion, patients will be given a RIC regimen based on the market-approved association of fludarabine and treosulfan (FT-RIC): * Fludarabine (concentrate for solution for injection/infusion) is a marketed purine analogue and antineoplastic agent. * Treosulfan (powder for solution for infusion) is a marketed alkylating medication

Primary Outcome Measure

The main objective is to evaluate the efficacy of FT-RIC regimen before Haplo-SCT for older and/or frail patients diagnosed with AML, who are not eligible for a MAC regimen. [ Time Frame: through study completion an average of 4 years ]

Central Contacts

• PAKRADOUNI Jihane
  0491223824
  [email protected]
• ARTHUR Allison
  0491223448
  [email protected]

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