Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT07238712
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia (AML)
  • Atypical Chronic Myeloid Leukemia
  • Chronic Myeloid Leukemia
  • Myelodysplastic Syndromes (MDS)
  • Myeloprolipherative Neoplsm

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    ; Days -1 through +21: ruxolitinib 10 mg/kg/day p.o.
  • Abatacept (Orencia) — DRUG
    Days -1,+5, +14, +21 abatacept 10 mg/kg/day i.v.

Study Details

Optimization of bendamustine-containg graft-versus-host disease (GVHD) prophylaxis to reduce the incidence of secondary haemophagocytic lymphohistiocytosis and GVHD

Key Dates

Start date
May 10, 2025
Status verified
Nov 2025
Primary completion
Dec 10, 2026
Completion
Dec 10, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Test cohort 1 - ruxolitinib
    Days +3 through +4: Bendamustine 50 mg/m2 iv x 2 days; Days +3 through +4: Cyclophosphamide 25 mg/kg iv x 2 days; Days -1 through +21: ruxolitinib 10 mg/kg/day p.o.; mycophenolate mofetil Days +5 through +35 30 mg/kg/day p.o.; Days +5 through +100: Tacrolimus 0.03 mg/kg/day with further correction by concentration
  • Experimental: Test cohort 2 - abatacept
    Days +3 through +4: Bendamustine 50 mg/m2 iv x 2 days; Days +3 through +4: Cyclophosphamide 25 mg/kg iv x 2 days; Days -1 through +21: ruxolitinib 10 mg/kg/day p.o.; mycophenolate mofetil Days +5 through +35 30 mg/kg/day p.o.; Days +5 through +100: Tacrolimus 0.03 mg/kg/day with further correction by concentration
  • Experimental: Experimental: Expansion cohort
    Days +3 through +4: Bendamustine 50 mg/m2 iv x 2 days; Days +3 through +4: Cyclophosphamide 25 mg/kg iv x 2 days; Days -1,+5, +14, +21 abatacept 10 mg/kg/day i.v.; Days +5 through +100: Tacrolimus 0.03 mg/kg/day with further correction by concentration

Primary Outcome Measure

Overall survival analysis [ Time Frame: 2 years ]

Central Contacts

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