MSC and Cyclophosphamide for Acute Graft-Versus-Host Disease (aGVHD) Prophylaxis
Phase 2
- Conditions
- LeukemiaMultiple Myeloma
- Interventions
- Biological: Mesenchymal stromal cells
- Registration Number
- NCT02270307
- Lead Sponsor
- National Research Center for Hematology, Russia
- Brief Summary
Evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.
- Detailed Description
This trial try to find a new way of refractory hematological malignancies treatment. Aim of this study evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Refractory forms of acute leukemia, but in complete remission (CR)
- Second and third remission of acute leukemia
- 2nd and 3rd chronic phase chronic myelogenous leukemia (CML) (or Ph + ALL)
- relapsed multiple myeloma
- advanced leukemia
Exclusion Criteria
- ICU
- Mechanical ventilation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MSC+CY Mesenchymal stromal cells Cyclophosphamide 50 mg/kg/day at +3, +4 day once daily after BMT Mesenchymal stromal cells 1\*10\^6/kg at day of recovery MSC+CY Cyclophosphamide Cyclophosphamide 50 mg/kg/day at +3, +4 day once daily after BMT Mesenchymal stromal cells 1\*10\^6/kg at day of recovery
- Primary Outcome Measures
Name Time Method Overall survival 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
BMT department
🇷🇺Moscow, Russian Federation