Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT06532084
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Sorafenib — DRUG
    Sorafenib 200 mg bid for 168 days starting in the time fram between engraftment with neutrophils \> 1.0 x 10\^9/L, white blood cells\> 1.5 x 10\^9/L, platelets\> 1.5 x 10\^9/L and day+100 after allogeneic hematopoietic cell trnaplantation

Study Details

This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where randomization is performed at first documentation of CR after engraftment.

Key Dates

First listed
Aug 1, 2024
Start date
May 22, 2024
Status verified
Jul 2024
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sorafenib prophylaxis
    Sorafenib 200 mg bid for 168 days starting before day+100 after HCT
  • No Intervention: Observation
    Usual care

Primary Outcome Measure

Event-free survival [ Time Frame: 2 years ]

Central Contacts

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