Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

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ClinicalTrials.gov Identifier: NCT02487069

Recruitment Status : Completed

First Posted : July 1, 2015

Last Update Posted : March 5, 2020

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

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

Study Description

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	876 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
Actual Primary Completion Date :	January 31, 2020
Actual Study Completion Date :	February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Chronic myeloid leukemia

MedlinePlus related topics: Organ Donation

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Myelodysplastic Syndromes Chronic Myeloid Leukemia Chronic Myeloproliferative Disorders

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Disease-free survival [ Time Frame: 3 year ]
Incidence of transplantation-related mortality [ Time Frame: 3 year ]
Incidence of graft-versus-host disease [ Time Frame: 3 year ]
Graft-versus-host disease include acute and chronic Graft-versus-host disease
Incidence of infection [ Time Frame: 3 year ]
Infection includes bacterial, fungal and viral infections.
hematopoietic reconstruction [ Time Frame: 1 year ]
Hematopoietic reconstruction includes the time of neutrophil and platelet reconstruction.

Eligibility Criteria

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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)

Contacts and Locations

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

Locations

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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515

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

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

More Information

Publications:

Luo Y, Xiao H, Lai X, Shi J, Tan Y, He J, Xie W, Zheng W, Zhu Y, Ye X, Yu X, Cai Z, Lin M, Huang H. T-cell-replete haploidentical HSCT with low-dose anti-T-lymphocyte globulin compared with matched sibling HSCT and unrelated HSCT. Blood. 2014 Oct 23;124(17):2735-43. doi: 10.1182/blood-2014-04-571570. Epub 2014 Sep 11.

Lu DP, Dong L, Wu T, Huang XJ, Zhang MJ, Han W, Chen H, Liu DH, Gao ZY, Chen YH, Xu LP, Zhang YC, Ren HY, Li D, Liu KY. Conditioning including antithymocyte globulin followed by unmanipulated HLA-mismatched/haploidentical blood and marrow transplantation can achieve comparable outcomes with HLA-identical sibling transplantation. Blood. 2006 Apr 15;107(8):3065-73. Epub 2005 Dec 27.

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Responsible Party:	Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:	NCT02487069
Other Study ID Numbers:	Alternative Donor HSCT-2015
First Posted:	July 1, 2015 Key Record Dates
Last Update Posted:	March 5, 2020
Last Verified:	March 2019

Additional relevant MeSH terms:

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Leukemia Hematologic Neoplasms Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Neoplasms by Site Leukemia, Myeloid Myeloproliferative Disorders Cyclosporine Mycophenolic Acid Methotrexate Cyclosporins	Antilymphocyte Serum Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents

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