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

Peking University

Status: Enrolling

Conditions: T Cell Lymphoma

Study type: Observational

Funder types: Other

Identifiers

NCT03672084

Allo-HSCT for PTCL

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 60 years old

Volunteers: No 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