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MSCs Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant aGVHD

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ClinicalTrials.gov Identifier: NCT02241018
Recruitment Status : Unknown
Verified September 2014 by Qifa Liu, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : September 16, 2014
Last Update Posted : September 16, 2014
Sponsor:
Collaborators:
Guangdong Provincial People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Southern Medical University, China
Peking University People's Hospital
Huazhong University of Science and Technology
Sun Yat-sen University
Academy Military Medical Science, China
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Brief Summary:
The purpose of this study is to compare the efficacy of CD25 monoclonal antibody and calcineurin inhibitors with or without mesenchymal stem cells (MSCs) in treating patients with steroid-resistant acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation.

Condition or disease Intervention/treatment Phase
Acute Graft-versus-host Disease Drug: CD25 monoclonal antibody Drug: calcineurin inhibitors Biological: MSCs Phase 2 Phase 3

Detailed Description:

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective therapy for several hematological disorders. Although good progress has been made in the prevention and treatment of side effects associated with transplantation, aGVHDremains a common and life-threatening complication with poor prognosis. Corticosteroids are still acted as the first-line treatments of aGVHD, with a response rate of 50-80. However, those who failed to initial therapy only have 10-30% long-term survival.

Mesenchymal stromal cells (MSCs) are a form of multipotent adult stem cells that can be isolated from many tissues, such as bone marrow (BM), adipose tissue and umbilical cord. Such cells possess the capacity to suppress immunological responses, support hematopoiesis and repair tissues. Clinical applications of human MSCs are evolving rapidly for preventing and treating GVHD. Although the results are still controversy, most prospective and retrospective data suggest that MSCs are effective to aGVHD.

In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded BM-derived MSCs from third-party donors combined with CD25 monoclonal antibody and calcineurin inhibitors in treating patients with aGVHD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cells Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Mesenchymal stem cells
MSCs will be given at a median dose of 1×10^6 cells/kg once weekly for 4 dose (as 1 cycle) or until CR. The response should be evaluated at 3 and 4 weeks. If symptoms of aGVHD progress at 3 weeks or the patients have NR at 4 weeks, these patients will switch to other therapy. If patients achieved PR at 4 weeks, another cycle will be given. Besides, CD25 monoclonal antibody (20mg/kg) will be administered at day 1,4,8,15, 21 and calcineurin inhibitors will also be used.
Drug: CD25 monoclonal antibody
Drug: calcineurin inhibitors
Biological: MSCs
Experimental: CD25 Mc Ab & calcineurin inhibitors
CD25 monoclonal antibody (20mg/kg, day 1,4,8,15,21) will be administered combined with calcineurin inhibitors. The response should be evaluated at 3 and 4 weeks. If symptoms of aGVHD progress at 3 weeks or the patients have NR at 4 weeks, these patients will switch to other therapy. If patients achieved PR at 4 weeks, another cycle will be given.
Drug: CD25 monoclonal antibody
Drug: calcineurin inhibitors



Primary Outcome Measures :
  1. The efficacy of treatment for steroid-resistant aGVHD [ Time Frame: 1 year ]
    The responses to aGVHD are according to the literature criteria, including completely response (CR), partial response (PR) and no response (NR), and CR is defined as resolution of all symptoms of aGVHD; PR is defined as a decrease by at least 1 GVHD stage in any 1 organ system without deterioration in others 24. Overall response (OR) includes CR and PR.


Secondary Outcome Measures :
  1. Incidence of infections [ Time Frame: 1 year ]
    Infections are mainly focused on cytomegalovirus (CMV) and Epstein-Barr virus ( EBV) infections during study treatments and within one year after study treatments.

  2. Incidence of primary underlying disease relapse [ Time Frame: 1 year ]
  3. Incidence of chronic GVHD [ Time Frame: 1 year ]


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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age of 14-65 years
  • steroid-resistant aGVHD
  • subjects (or their legally acceptable representatives) must have signed an informed consent document

Exclusion Criteria:

  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  • Patients with any conditions not suitable for the trial (investigators' decision)

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): NCT02241018


Contacts
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Contact: Ren Lin +86-020-62787883 lansinglinren@hotmail.com

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Ren Lin, MD    +86-020-62787883    lansinglinren@hotmail.com   
Principal Investigator: Qifa Liu, MD         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Guangdong Provincial People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Southern Medical University, China
Peking University People's Hospital
Huazhong University of Science and Technology
Sun Yat-sen University
Academy Military Medical Science, China
Investigators
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Principal Investigator: Qifa Liu, MD Nanfang Hospital of Southern Medical University

Publications:
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Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02241018    
Other Study ID Numbers: NFH-MSC-aGVHD-2014
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014
Keywords provided by Qifa Liu, Nanfang Hospital of Southern Medical University:
Hematopoietic Stem Cell Transplantation
Mesenchymal Stem Cells
CD25 Monoclonal Antibody
Acute Graft-versus-host disease
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Calcineurin Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action