Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

Myelodysplastic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487069
• Other study ID #: Alternative Donor HSCT-2015
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: February 29, 2020

Study information

• Verified date: March 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 876
• Est. completion date: February 29, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Leukemia
• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes

Intervention

Procedure:
• HSCT from MSD
HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.
• 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.
• 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.
• Methotrexate
MTX is used in all the patients for GVHD prophylaxis.
• 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.
• Mycophenolate mofetil
MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.

Locations

Country	Name	City	State
China	Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (12)

Lead Sponsor

Collaborator

Nanfang Hospital of Southern Medical University

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

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	The primary endpoint is overall survival within 3 years after HSCT.	3 year
Secondary	Disease-free survival		3 year
Secondary	Incidence of transplantation-related mortality		3 year
Secondary	Incidence of graft-versus-host disease	Graft-versus-host disease include acute and chronic Graft-versus-host disease	3 year
Secondary	Incidence of infection	Infection includes bacterial, fungal and viral infections.	3 year
Secondary	hematopoietic reconstruction	Hematopoietic reconstruction includes the time of neutrophil and platelet reconstruction.	1 year