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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    50
  • sponsor
    Peking University People's Hospital
Updated on 25 January 2021
cancer
stem cell transplantation
hematologic malignancy
cell transplantation
t-cell lymphoma
peripheral t-cell lymphoma

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

Details
Condition Lymphoma, T-Cell Lymphoma, Non-Hodgkin's Lymphoma, t cell lymphoma
Clinical Study IdentifierNCT03672084
SponsorPeking University People's Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 2 yrs and 60 yrs?
Gender: Male or Female
Do you have any of these conditions: T-Cell Lymphoma or Non-Hodgkin's Lymphoma or Lymphoma?
Do you have any of these conditions: t cell lymphoma or Non-Hodgkin's Lymphoma or Lymphoma or T-Cell Lymphoma?
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
Clear my responses

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