NCT02487069

Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 876 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Leukemia
• Chronic Myeloid Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
PROCEDURE	HSCT from MSD	HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.
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.
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.
DRUG	Methotrexate	MTX is used in all the patients for GVHD prophylaxis.
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.
DRUG	Mycophenolate mofetil	MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.

Timeline

• Start date: 2015-06-01
• Primary completion: 2020-01-31
• Completion: 2020-02-29
• First posted: 2015-07-01
• Last updated: 2020-03-05

Locations

1 site across 1 country: China