- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02270307
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 Contact
- Name: Elena N Parovichnikova, PhD,MD
- Phone Number: +79161252623
- Email: elenap@blood.ru
Study Contact Backup
- Name: Mikhail Y Drokov, PhD,MD
- Phone Number: +79261841813
- Email: mdrokov@gmail.com
Study Locations
-
-
-
Moscow, Russian Federation
- Recruiting
- BMT department
-
Contact:
- Elena Parovichnikova, Prof MD PhD
- Phone Number: +79161487131
- Email: kuzlara@rambler.ru
-
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
|
Dose 50 mg/kg at day +3,+4 once daily
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.
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
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Multiple Myeloma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
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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