Venetoclax in Patients With MDS or AML in Relapse After AHSCT

Sponsor
Groupe Francophone des Myelodysplasies
Study ID
NCT05226455
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Study to assess venetoclax + azacitidine and donor lymphocyte infusion (DLI) in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) in relapse after allohematopoietic stem cell transplantation (AHSCT).

Key Dates

Start date
Nov 23, 2022
Status verified
Mar 2026
Primary completion
Nov 15, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: venetoclax + azacitidine +/- donor lymphocyte infusion
    Venetoclax + azacitidine +/- donor lymphocyte infusion (maximum 12 cycles). Venetoclax: on D1 to D14 of 28 days cycle ; Phase I: 4 dose levels: 50, 100, 200, 400 mg/d, starting dose at 100 mg ; Phase II: dose defined in the phase I. Azacitidine 75 mg/m²/d or 50 mg/m²/d (if allohematopoietic stem cell transplantation relapse \< 4 months) x 5 days (on D1 to D5 of 28 days cycle).

Primary Outcome Measure

Phase I: Dose-finding study [ Time Frame: At the end of cycle 1 of venetoclax + azacitidine (each cycle is 28 days) ]

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