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Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

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ClinicalTrials.gov Identifier: NCT02487069
Recruitment Status : Recruiting
First Posted : July 1, 2015
Last Update Posted : October 20, 2017
Sponsor:
Collaborators:
Guangdong General 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
Zhujiang Hospital
Tongji Hospital
Wuhan Union Hospital, China
Fujian Medical University Union Hospital
First Affiliated Hospital of Guangxi Medical University
Xiangya Hospital of Central South University
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 allogeneic hematopoietic stem cell transplantation (allo-HSCT) from matched sibling donor (MSD),matched unrelated donor (MUD) and haploidentical related donors(HRD) in the treatment of hematologic malignancy.

Condition or disease Intervention/treatment Phase
Acute Leukemia Chronic Myeloid Leukemia Myelodysplastic Syndrome Procedure: HSCT from MSD Procedure: HSCT from MUD Procedure: HSCT from HRD Drug: Cyclosporin A Drug: Methotrexate Drug: Antithymocyte globulin Drug: Mycophenolate mofetil Not Applicable

Detailed Description:
Currently, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy for a majority of malignant hematologic diseases, especially acute leukemia. HSCT from MSD offers the best results for these diseases, but lack of this donor resource has restricted its wide application. HSCT from MUD provides another option, but MUDs still cannot satisfy all patients due to unsuccessful donor searches. Almost all patients have an available related donor with whom they share a single HLA haplotype (ie, haploidentical related donor), and it owns the advantage of immediate availability, especially for those who urgently need transplantation.The results of transplantation from HRD have improved significantly over the past few years. However, the results from such haploidentical transplantation have not formally been compared with those of transplantation in patients contemporaneously using MSDs and MUDs for hematologic malignancy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Stem Cell Transplantation With Alternative Donor in Treatment of Hematologic Malignancy
Study Start Date : June 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Experimental: MSD group
The patients will received HSCT from MSD.
Procedure: HSCT from MSD
HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.

Drug: Cyclosporin A
CsA is used in all the patients for GVHD prophylaxis.
Other Name: CsA

Drug: Methotrexate
MTX is used in all the patients for GVHD prophylaxis.
Other Name: MTX

Drug: Mycophenolate mofetil
MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.
Other Name: MMF

Experimental: MUD group
The patients will received HSCT from MUD.
Procedure: HSCT from MUD
HSCT from MUD is the second choice for the patients who don't have HLA-matched sibling donors but have HLA-matched unrelated donors.

Drug: Cyclosporin A
CsA is used in all the patients for GVHD prophylaxis.
Other Name: CsA

Drug: Methotrexate
MTX is used in all the patients for GVHD prophylaxis.
Other Name: MTX

Drug: Antithymocyte globulin
ATG is used in the patients receiving HSCT from MUD and HRD for GVHD prophylaxis.In MUD group,total ATG doses is 7 mg/kg;In HRD group,total ATG doses is 7.5 or 10 mg/kg.
Other Name: ATG

Experimental: HRD group
The patients will received HSCT from HRD.
Procedure: HSCT from HRD
HSCT from HRD is the choice for the patients who have neither HLA-matched sibling donors nor HLA-matched unrelated donors.

Drug: Cyclosporin A
CsA is used in all the patients for GVHD prophylaxis.
Other Name: CsA

Drug: Methotrexate
MTX is used in all the patients for GVHD prophylaxis.
Other Name: MTX

Drug: Antithymocyte globulin
ATG is used in the patients receiving HSCT from MUD and HRD for GVHD prophylaxis.In MUD group,total ATG doses is 7 mg/kg;In HRD group,total ATG doses is 7.5 or 10 mg/kg.
Other Name: ATG

Drug: Mycophenolate mofetil
MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.
Other Name: MMF




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 year ]
    The primary endpoint is overall survival within 3 years after HSCT.


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3 year ]
  2. Incidence of transplantation-related mortality [ Time Frame: 3 year ]
  3. Incidence of graft-versus-host disease [ Time Frame: 3 year ]
    Graft-versus-host disease include acute and chronic Graft-versus-host disease

  4. Incidence of infection [ Time Frame: 3 year ]
    Infection includes bacterial, fungal and viral infections.

  5. hematopoietic reconstruction [ Time Frame: 1 year ]
    Hematopoietic reconstruction includes the time of neutrophil and platelet reconstruction.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary disease is acute leukemia/MDS/CML
  • Receiving allo-HSCT

Exclusion Criteria:

  • cardiac dysfunction (particularly congestive heart failure)
  • hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase> 2 times the upper limit of normal)
  • renal dysfunction (creatinine clearance rate < 30 mL/min)
  • 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): NCT02487069


Contacts
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Contact: Zhiping Fan +86-020-62787883 hnfzping@hotmail.com

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Zhiping Fan    +86-020-62787883    hnfzping@hotmail.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Guangdong General 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
Zhujiang Hospital
Tongji Hospital
Wuhan Union Hospital, China
Fujian Medical University Union Hospital
First Affiliated Hospital of Guangxi Medical University
Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Qifa Liu 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: NCT02487069     History of Changes
Other Study ID Numbers: Alternative Donor HSCT-2015
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: June 2015
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Myeloid
Myeloproliferative Disorders
Cyclosporine
Mycophenolic Acid
Methotrexate
Cyclosporins
Antilymphocyte Serum
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antifungal Agents