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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03672084
Enrollment
50
Registered
2018-09-14
Start date
2019-01-01
Completion date
2023-12-31
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
1 year PFSparticipants will be follow for an expected average of 365 daysprogression free survival

Countries

China

Contacts

Primary ContactFengRong Wang, MD
fr.wangt@139.com8610-88324577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026