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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02270307

Acronym

MSC-CY

Enrollment

Registered

2014-10-21

Start date

2014-01-31

Completion date

2016-01-31

Last updated

2014-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Multiple Myeloma

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.

Interventions

DRUGCyclophosphamide

Dose 50 mg/kg at day +3,+4 once daily

BIOLOGICALMesenchymal stromal cells

Dose 1 million per kg, at day of recovery once

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Overall survival	1 year

Countries

Russia

Contacts

Primary ContactElena N Parovichnikova, PhD,MD

elenap@blood.ru+79161252623

Backup ContactMikhail Y Drokov, PhD,MD

mdrokov@gmail.com+79261841813

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026