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

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Brief Title

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

Official Title

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

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
    


Study Type

Observational


Primary Outcome

1 year PFS


Condition

T Cell Lymphoma



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

50

Start Date

January 1, 2019

Completion Date

December 2023

Primary Completion Date

August 2021

Eligibility Criteria

        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
      

Gender

All

Ages

2 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Xiao-Jun Huang, MD, 8610-88324577, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03672084

Organization ID

Allo-HSCT for PTCL


Responsible Party

Principal Investigator

Study Sponsor

Peking University People's Hospital


Study Sponsor

Xiao-Jun Huang, MD, Principal Investigator, Peking University


Verification Date

September 2020