Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

March 3, 2020 updated by: Qifa Liu, Nanfang Hospital of Southern Medical University

Allogeneic Stem Cell Transplantation With Alternative Donor in Treatment of Hematologic Malignancy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

876

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • CsA
Drug: Methotrexate
MTX is used in all the patients for GVHD prophylaxis.
Other Names:
  • MTX
Drug: Mycophenolate mofetil
MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.
Other Names:
  • MMF
EXPERIMENTAL: MUD group
The patients will received HSCT from MUD.
Drug: Cyclosporin A
CsA is used in all the patients for GVHD prophylaxis.
Other Names:
  • CsA
Drug: Methotrexate
MTX is used in all the patients for GVHD prophylaxis.
Other Names:
  • MTX
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: 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 Names:
  • ATG
EXPERIMENTAL: HRD group
The patients will received HSCT from HRD.
Drug: Cyclosporin A
CsA is used in all the patients for GVHD prophylaxis.
Other Names:
  • CsA
Drug: Methotrexate
MTX is used in all the patients for GVHD prophylaxis.
Other Names:
  • MTX
Drug: Mycophenolate mofetil
MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.
Other Names:
  • MMF
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 Names:
  • ATG
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 3 year
The primary endpoint is overall survival within 3 years after HSCT.
3 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Xiangya Hospital of Central South University
Tongji Hospital
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangdong Provincial People's Hospital
Zhujiang Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Wuhan Union Hospital, China
Fujian Medical University Union Hospital
Guangzhou General Hospital of Guangzhou Military Command
First Affiliated Hospital of Guangxi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

January 31, 2020

Study Completion (ACTUAL)

February 29, 2020

Study Registration Dates

First Submitted

June 14, 2015

First Submitted That Met QC Criteria

June 27, 2015

First Posted (ESTIMATE)

July 1, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alternative Donor HSCT-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Myeloid Leukemia

Clinical Trials on HSCT from MSD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe