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

Sponsor

Peking University People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03672084

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
T Cell Lymphoma

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1 year PFS [participants will be follow for an expected average of 365 days]
progression free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing		China	100044

Sponsors and Collaborators

Peking University People's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiao-Jun Huang, PI, Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT03672084

Other Study ID Numbers:

Allo-HSCT for PTCL

First Posted:

Sep 14, 2018

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Study Results

No Results Posted as of Aug 2, 2022