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Chi-GVM Regimen for the Treatment of R/R PTCL

NCT06211881 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-01-18

No results posted yet for this study

Summary

Peripheral T-cell lymphoma (PTCL) is a heterogeneous group of lymphoproliferative diseases caused by mature T cells, accounting for approximately 10% of non-Hodgkin lymphomas (NHL). PTCLs have a worse prognosis than aggressive B-cell lymphomas; they are less responsive to standard anthracycline-based chemotherapy regimens and responses are less durable. In an analysis of 341 patients with newly diagnosed PTCL who received anthracycline chemotherapy, 3-year PFS and OS rates were 32% and 52%, respectively, significantly inferior to matched patients with diffuse large B-cell lymphoma (DLBCL).And patients who received consolidative hematopoietic cell transplantation (HCT) had no significant benefit. The prognosis of relapsed/refractory (R/R) patients is even worse. Among the 420 evaluable R/R PTCL patients in the COMPLETE registration study, the median OS of R/R patients were 29 months and 12 months respectively . There is still no effective second-line regimen that can improve patient survival, so treatment options urgently need to be optimized.We designed a randomized, prospective, multi-center phase II clinical trial to explore the efficacy of chidamide combined with gemcitabine, vinorelbine and Mitoxantrone Hydrochloride Liposome (Chi-GVM) in the treatment of patients with R/R PTCL. We expected to further improve ORR, PFS and OS.

Conditions

  • Relapsed/Refractory Peripheral T-cell Lymphoma

Interventions

DRUG

Chi-GVM

Chi-GVM regimen (every 21 days is a treatment cycle): Chidamide 20 mg orally;gemcitabine 1g/m2, twice a week, intravenous infusion on day 1, vinorelbine 20 mg/m2, infusion on day 1; Mitoxantrone Hydrochloride Liposome12 mg/m2, intravenous infusion on day 1; Chidamide maintenance therapy: 20 mg orally twice a week/28 days/cycle.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • wei Xu, Doctor · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06211881 on ClinicalTrials.gov