NCT02270307

MSC and Cyclophosphamide for Acute Graft-Versus-Host Disease (aGVHD) Prophylaxis

Allogeneic Bone Marrow Transplantation (Allo-BMT) From Human Leukocyte Antigen (HLA) - Identical Related and Unrelated Donors in Patients With Hematological Malignancies With High Risk of Relapse Using Cyclophosphamide (CY) and Mesenchymal Stromal Cells (MSC) as aGVHD Prophylaxis

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Research Center for Hematology, Russia · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Dose 50 mg/kg at day +3,+4 once daily
BIOLOGICAL	Mesenchymal stromal cells	Dose 1 million per kg, at day of recovery once

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-10-21
• Last updated: 2014-10-21

Locations

1 site across 1 country: Russia