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NCT03672084 Clinical Trial

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

T Cell Lymphoma Clinical Trial

Official title:
Allogeneic Hematopoietic Stem Cell Transplantation Following Conventional Chemotherapy in High Risk Peripheral T Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03672084
Other study ID # Allo-HSCT for PTCL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 2023

Study information
Verified date July 2022
Source Peking University People's Hospital
Contact FengRong Wang, MD
Phone 8610-88324577
Email fr.wangt@139.com
Is FDA regulated No
Health authority
Study type Observational

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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2023
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years to 60 Years
Eligibility Inclusion Criteria: - Primary diagnosis of mature T-cell lymphoma, stage 2-4, or stage 1 with aa IPI>=0 - age <= 60 years - KPS>=70 Exclusion Criteria: - stage I with aaIPI 0, ALCL ALK positive, T-lymphoblastic lymphoma, cutaneous T-cell lymphoma - HIV positivity - major organ dysfunction - pregnancy - patient unable to give informed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Peking University People's Hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1 year PFS progression free survival participants will be follow for an expected average of 365 days
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