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Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

Primary Purpose

Acute Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HSCT from MSD
HSCT from MUD
HSCT from HRD
Cyclosporin A
Methotrexate
Antithymocyte globulin
Mycophenolate mofetil
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Hematology,Nanfang Hospital, Southern Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MSD group

MUD group

HRD group

Arm Description

The patients will received HSCT from MSD.

The patients will received HSCT from MUD.

The patients will received HSCT from HRD.

Outcomes

Primary Outcome Measures

Overall Survival
The primary endpoint is overall survival within 3 years after HSCT.

Secondary Outcome Measures

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

Full Information

First Posted
June 14, 2015
Last Updated
March 3, 2020
Sponsor
Nanfang Hospital, Southern Medical University
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
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1. Study Identification

Unique Protocol Identification Number
NCT02487069
Brief Title
Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy
Official Title
Allogeneic Stem Cell Transplantation With Alternative Donor in Treatment of Hematologic Malignancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
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

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
876 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MSD group
Arm Type
Experimental
Arm Description
The patients will received HSCT from MSD.
Arm Title
MUD group
Arm Type
Experimental
Arm Description
The patients will received HSCT from MUD.
Arm Title
HRD group
Arm Type
Experimental
Arm Description
The patients will received HSCT from HRD.
Intervention Type
Procedure
Intervention Name(s)
HSCT from MSD
Intervention Description
HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.
Intervention Type
Procedure
Intervention Name(s)
HSCT from MUD
Intervention Description
HSCT from MUD is the second choice for the patients who don't have HLA-matched sibling donors but have HLA-matched unrelated donors.
Intervention Type
Procedure
Intervention Name(s)
HSCT from HRD
Intervention Description
HSCT from HRD is the choice for the patients who have neither HLA-matched sibling donors nor HLA-matched unrelated donors.
Intervention Type
Drug
Intervention Name(s)
Cyclosporin A
Other Intervention Name(s)
CsA
Intervention Description
CsA is used in all the patients for GVHD prophylaxis.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
MTX
Intervention Description
MTX is used in all the patients for GVHD prophylaxis.
Intervention Type
Drug
Intervention Name(s)
Antithymocyte globulin
Other Intervention Name(s)
ATG
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Other Intervention Name(s)
MMF
Intervention Description
MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.
Primary Outcome Measure Information:
Title
Overall Survival
Description
The primary endpoint is overall survival within 3 years after HSCT.
Time Frame
3 year
Secondary Outcome Measure Information:
Title
Disease-free survival
Time Frame
3 year
Title
Incidence of transplantation-related mortality
Time Frame
3 year
Title
Incidence of graft-versus-host disease
Description
Graft-versus-host disease include acute and chronic Graft-versus-host disease
Time Frame
3 year
Title
Incidence of infection
Description
Infection includes bacterial, fungal and viral infections.
Time Frame
3 year
Title
hematopoietic reconstruction
Description
Hematopoietic reconstruction includes the time of neutrophil and platelet reconstruction.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qifa Liu
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology,Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25214441
Citation
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.
Results Reference
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PubMed Identifier
16380454
Citation
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. doi: 10.1182/blood-2005-05-2146. Epub 2005 Dec 27.
Results Reference
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Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

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