The objective of the study was to present long-term follow-up data with updated time to disease progression (TTP) and duration of response (DR) from a multicenter, phase II trial of R-CHOP combination therapy in 40 patients with CD20+, B-cell NHL. Primary endpoints: ORR, PR rate and CR rate; secondary endpoints: TTP, DR.

Researchers concluded that although a cure has not been found yet for follicular NHL, the R-CHOP combination provides a lengthy response duration in patients with relapsed or newly diagnosed indolent NHL

Official Title

Prolonged clinical and molecular remission in patients with low-grade or follicular non-Hodgkin’s lymphoma treated with rituximab plus CHOP chemotherapy: 9-year follow-up

Conditions

Study Type

Follow-up of a phase II, open-label, single-arm, multicenter study

Study Design

Six cycles of CHOP and 6 infusions of rituximab (2 before the first cycle of CHOP, one each before the third and fifth cycle of CHOP, and two after the sixth cycle).

Further Details

Efficacy:CR + unconfirmed CR: 33/38 (87%)PR: 5/38 (13%)Med TTP: 82.3 moMed DR: 83.5 moOngoing responders (6-9 cycles): 16Tolerability:Described in a previous publication in detail.Most frequent and severe adverse events related to CHOP:Hematologic effects, nausea, vomiting and alopecia.Most frequent rituximab events: chills, fever, pruritus, headache.

Study Start

Eligibility & Criteria

Histologically confirmed, low-grade or follicular, B-cell lymphoma; no prior chemotherapy or no more than 4 prior standard therapy, acceptable hematologic status.

Total Enrolment

40 (38 treated)

Contact Details

Czuczman MS, Weaver R, Alkuzweny B, Berlfein J, Grillo-Lopez AJJournal of Clinical Oncology 22 (2004): 4659-4664

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