Allo-HSCT as First-line Consolidation in High-risk PTCL

Status Recruiting

Clinical Trial Summary

Results of conventional therapy in patients with peripheral T-cell lymphoma(PTCL) are poor. Allogeneic hematopoietic stem cell transplantation(allo-HSCT) gave excellent results in PTCL after failure of conventional therapy and in many cases also of HDT/ASCT. A disadvantage of allo-HSCT is high TRM rate, especially in refractory or relapsed patients. Another limitation to the use of allo-HSCT is the availability of a HLA matched donors. Haploidentical family donors have been successfully used in treatments of hematologic malignancies, including malignant lymphomas. Thus, allo-HSCT could be used as first-line consolidation following conventional chemotherapy in high-risk PTCL patients. The study hypothesis: Using allo-HSCT as consolidation following chemotherapy in high-risk PTCL exerts a strong anti-lymphoma effect and could increase response rate and improve long term survival.

Clinical Trial Description

After primary diagnosis eligible patients receive 2 to 3 courses of CHOEP-21 with formal restaging after course 2. Patients with CR, PR or no change proceed to allo-HSCT. Donor selection: Matched sibling donor(MSD) is the first choice. An unrelated donor or haploidentical family donor search is performed in patients without sibling donor. The primary end point was 1 year progression-free survival. The secondary end points were complete commission rate, transplant-related mortality, overall survival, relapse rate and graft-versus-host disease (GVHD) . Following time is 2 years ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03672084
Study type	Observational
Source	Peking University People's Hospital
Contact	FengRong Wang, MD
Phone	8610-88324577
Email	fr.wangt@139.com
Status	Recruiting
Phase
Start date	January 1, 2019
Completion date	December 2023

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