NCT03672084

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

4.6 years

First QC Date

September 13, 2018

Last Update Submit

July 31, 2022

Conditions

T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 1 year PFS

    progression free survival

    participants will be follow for an expected average of 365 days

Eligibility Criteria

Age2 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Mature T-cell lymphoma patietnts, stage 2-4, or stage 1 with aa IPI\>=0 * age \<= 60 years * KPS\>=70

You may qualify if:

  • Primary diagnosis of mature T-cell lymphoma, stage 2-4, or stage 1 with aa IPI\>=0
  • age \<= 60 years
  • KPS\>=70

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Xiao-Jun Huang, MD

    Peking University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

FengRong Wang, MD

CONTACT

8610-88324577fr.wangt@139.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 14, 2018

Study Start

January 1, 2019

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

August 2, 2022

Record last verified: 2022-07

Locations

CN(1)