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

Primary Purpose

Leukemia, Multiple Myeloma

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Cyclophosphamide
Mesenchymal stromal cells
Sponsored by
National Research Center for Hematology, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leukemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • BMT departmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MSC+CY

Arm 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

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Full Information

First Posted
April 7, 2014
Last Updated
October 17, 2014
Sponsor
National Research Center for Hematology, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT02270307
Brief Title
MSC and Cyclophosphamide for Acute Graft-Versus-Host Disease (aGVHD) Prophylaxis
Acronym
MSC-CY
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Center for Hematology, Russia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Multiple Myeloma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MSC+CY
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Dose 50 mg/kg at day +3,+4 once daily
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stromal cells
Intervention Description
Dose 1 million per kg, at day of recovery once
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena N Parovichnikova, PhD,MD
Phone
+79161252623
Email
elenap@blood.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Mikhail Y Drokov, PhD,MD
Phone
+79261841813
Email
mdrokov@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valery Savchenko, Prof.
Organizational Affiliation
Ministry of Health
Official's Role
Study Director
Facility Information:
Facility Name
BMT department
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Parovichnikova, Prof MD PhD
Phone
+79161487131
Email
kuzlara@rambler.ru
First Name & Middle Initial & Last Name & Degree
Elena Parovichnikova

12. IPD Sharing Statement

Learn more about this trial

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

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