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

October 17, 2014 updated by: Elena N.Parovichnikova, National Research Center for Hematology, Russia

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • BMT department
        • Contact:
        • Principal Investigator:
          • Elena Parovichnikova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MSC+CY
Cyclophosphamide 50 mg/kg/day at +3, +4 day once daily after BMT Mesenchymal stromal cells 1*10^6/kg at day of recovery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Center for Hematology, Russia

Investigators

  • Study Director: Valery Savchenko, Prof., Ministry of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

October 17, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 17, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSC-CY-Russia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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