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PCR (Pentostatin, Cyclophosphamide, Rituximab) in Low-Grade B-Cell Non-Hodgkin's Lymphoma

NCT00496873Phase 2

Key facts

Status: Completed
Start: Jun 2005
Primary completion: Dec 2014
Countries: 1
Sponsor: University of Texas MD Anderson Cancer Center
Modality: Orthosteric Ligands, Metabolically Activated Prodrugs

Drugs: pentostatin
Conditions: non-Hodgkin lymphoma (NHL)

Overview

Phase 2, open-label, single-arm trial of pentostatin in non-Hodgkin lymphoma (NHL), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoints: Participant Response Rate According to IWG Response Criteria and Number of Participants With Complete Response (CR)/Complete Response Unconfirmed (CRu). Started Jun 2005; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Cytoxan + Rituxan + Nipent
Combination of Pentostatin, Cyclophosphamide, and Rituximab.

Who it enrols

Patients with stage III/IV low-grade B-cell NHL or bulky lymphoma, CD20+, 0-1 prior regimens. Adequate organ function required.

Endpoints

Primary

Participant Response Rate According to IWG Response CriteriaCycles 3, 6, 9 (up to 7 months)
Number of Participants With Complete Response (CR)/Complete Response Unconfirmed (CRu)9 cycles (up to 7 months)

Secondary

3-Year Progression-Free Survival3 years

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