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Status unknownNCT03672084Updated Aug 2, 2022

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

An observational study in T Cell Lymphoma, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 2 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-08-02.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
2 Years to 60 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 50 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Mature T-cell lymphoma patietnts, stage 2-4, or stage 1 with aa IPI>=0

  • age \<= 60 years
  • KPS>=70

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 1 year PFS

    progression free survival

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

07

Study locations

1 of 1 sites recruiting
  • Peking University People's Hospital
    Beijing, 100044, China
    • FengRong Wang · Contact · 861088326666
    • xiaojun huang, M.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03672084
Lead sponsor
Peking University People's Hospital
Responsible party
Xiao-Jun Huang (PI, Peking University People's Hospital) — Principal investigator
First posted
Sep 14, 2018
Start date
Jan 1, 2019
Primary completion
Aug 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Aug 2, 2022

Study contacts

FengRong Wang, MD
Contact
fr.wangt@139.com
8610-88324577
Xiao-Jun Huang, MD
principal investigator · Peking University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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