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

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ClinicalTrials.gov Identifier: NCT02270307
Recruitment Status : Unknown
Verified October 2014 by Elena N.Parovichnikova, National Research Center for Hematology, Russia.
Recruitment status was:  Recruiting
First Posted : October 21, 2014
Last Update Posted : October 21, 2014
Sponsor:
Information provided by (Responsible Party):
Elena N.Parovichnikova, National Research Center for Hematology, Russia

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.

Condition or disease Intervention/treatment Phase
Leukemia Multiple Myeloma Drug: Cyclophosphamide Biological: Mesenchymal stromal cells Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : January 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016


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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270307


Contacts
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Contact: Elena N Parovichnikova, PhD,MD +79161252623 elenap@blood.ru
Contact: Mikhail Y Drokov, PhD,MD +79261841813 mdrokov@gmail.com

Locations
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Russian Federation
BMT department Recruiting
Moscow, Russian Federation
Contact: Elena Parovichnikova, Prof MD PhD    +79161487131    kuzlara@rambler.ru   
Principal Investigator: Elena Parovichnikova         
Sponsors and Collaborators
National Research Center for Hematology, Russia
Investigators
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Study Director: Valery Savchenko, Prof. Netherlands: Ministry of Health, Welfare and Sports

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Responsible Party: Elena N.Parovichnikova, PI, National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier: NCT02270307     History of Changes
Other Study ID Numbers: MSC-CY-Russia
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists