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

National Research Center for Hematology, Russia40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Leukemia Multiple Myeloma

Interventions

CyclophosphamideDRUG

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

Mesenchymal stromal cellsBIOLOGICAL

Dose 1 million per kg, at day of recovery once

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

BMT department

Moscow, Russia

RECRUITING

Outcomes

Primary Outcomes

Overall survival

Time frame: 1 year

Central Contacts

Elena N Parovichnikova, PhD,MD

CONTACT

+79161252623 elenap@blood.ru

Mikhail Y Drokov, PhD,MD

CONTACT

+79261841813 mdrokov@gmail.com

Data from ClinicalTrials.gov

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