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

National Research Center for Hematology, Russia

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Multiple Myeloma; Leukemia

Treatments: Biological: Mesenchymal stromal cells; Drug: Cyclophosphamide

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02270307

MSC-CY-Russia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

MSC+CY

Experimental group

Description:

Cyclophosphamide 50 mg/kg/day at +3, +4 day once daily after BMT Mesenchymal stromal cells 1\*10\^6/kg at day of recovery

Treatment:

Drug: Cyclophosphamide

Biological: Mesenchymal stromal cells