Trial intelligence / Profile preview

Bortezomib Combined With ACVBP in Untreated Peripheral T-cell Lymphoma

NCT00136565Phase 2

Key facts

Status: Completed
Start: Jan 2006
Primary completion: Apr 2011
Countries: 2
Sponsor: Lymphoma Study Association
Modality: Small Molecules, Modified Peptides

Drugs: bortezomib
Conditions: peripheral T-cell lymphoma (PTCL)

Overview

Phase 2, open-label, single-arm trial of bortezomib in peripheral T-cell lymphoma (PTCL), sponsored by Lymphoma Study Association. Primary endpoint: Event-free survival at 2 years. Started Jan 2006; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Experimental
Bortezomib combined with ACVBP chemotherapy

Who it enrols

Patients aged 18-65 with previously untreated non-cutaneous peripheral T-cell lymphoma (including HTLV-1 and NK-cell lymphoma). Excludes B-cell lymphoma, ALK+ anaplastic large cell lymphoma, lymphoblastic lymphoma, and primary cutaneous T-cell lymphoma. Patients must have adequate renal, liver, and bone marrow function and no CNS involvement.

Endpoints

Primary

Event-free survival2 years

Secondary

Complete response rate unconfirmed2 years
Partial response rate2 years
Progression free survival2 years
Duration of response in complete responders2 years
Overall survival2 years
Number of SAE2 years

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