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Recruiting Phase 2 NCT06244368

GVM±R in Patients With Relapsed or Refractory Aggressive NHL.

Trial Parameters

Condition Peripheral T Cell Lymphoma
Sponsor Institute of Hematology & Blood Diseases Hospital, China
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 115
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-01-17
Completion 2025-12-30
Interventions
GVM±R regimen

Brief Summary

This is a prospective clinical study to evaluate the safety and efficacy of GVM±R in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18, ≤65 years. 2. Expected survival ≥ 3 months. 3. Subjects with aggressive NHL who have relapsed or proven refractory to at least one line of standard therapy or have achieved PR as the best response after a minimum of 4 cycles of therapy (patients with a Deauville score of 4 must have biopsy-proven residual disease). Relapse is defined as a disease response (PR/CR) to the last-line therapy with a duration of response exceeding 6 months. Refractory disease can be confirmed under any of the following conditions: 1) no partial or complete response to the last-line therapy; 2) the duration of complete or partial response to the last-line therapy is no longer than 6 months from the last dose of therapy; 3) Recurrence after hematopoietic stem cell transplantation. 4. Subjects must have at least one measurable lesion per lugano2014 criteria: for lymph node lesions, the long diameter should be \> 1.5cm; For non-lymph node lesions, the long diameter should be \> 1.

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