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Clinical Trials/NCT03672084
NCT03672084
Unknown
Not Applicable

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

Peking University People's Hospital1 site in 1 country50 target enrollmentJanuary 1, 2019
ConditionsT Cell Lymphoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
T Cell Lymphoma
Sponsor
Peking University People's Hospital
Enrollment
50
Locations
1
Primary Endpoint
1 year PFS
Last Updated
3 years ago

Overview

Brief 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.

Detailed 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

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiao-Jun Huang

PI

Peking University People's Hospital

Eligibility Criteria

Inclusion Criteria

  • Primary diagnosis of mature T-cell lymphoma, stage 2-4, or stage 1 with aa IPI\>=0
  • age \<= 60 years

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

Outcomes

Primary Outcomes

1 year PFS

Time Frame: participants will be follow for an expected average of 365 days

progression free survival

Study Sites (1)

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