Optimization of the First-line Therapy of T-cell Lymphomas (BrEto-TCL)

NCT07258680 Phase 3 ENROLLING_BY_INVITATION

There is no data comparing the effectiveness of the 4 most relevant first-line therapy programs for peripheral T-cell lymphomas (CHOEP, CHOP, CHEP-BV, CHP-BV) in a single study. For the first time, the effectiveness and toxicity of various first-line PTCL therapy programs in patients with T-cell lymphoma will be analyzed in the conditions of a single medical center of the N.N.Petrov National Research Medical Center of Oncology and optimal therapeutic tactics will be determined, taking into account significant prognostic factors based on effectiveness and toxicity a specific chemotherapy regimen.

Details

Lead sponsor	N.N. Petrov National Medical Research Center of Oncology
Phase	Phase 3
Status	ENROLLING_BY_INVITATION
Enrolment	114
Start date	2013-10
Completion	2028-12

Conditions

• Peripheral T-cell Lymphoma

Interventions

• Doxorubicin
• Vincristine
• Etoposide
• cyclophosphamide
• Prednisone
• Brentuximab Vedotin (Bv)

Primary outcomes

• complete response rate — Up to 8 months
  \- Primary endpoints: the complete response rate - The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.