BRIGHT: trial | Bending the Curve: Trial by Trial

BRIGHT

Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study

Phase 3N = 447NCT00877006

Population

Treatment-naive indolent non-Hodgkin lymphoma or mantle cell lymphoma (the abstracts do not give the follicular subset).

Design

Randomised, non-inferiority, global phase 3 study in treatment-naive indolent non-Hodgkin lymphoma or mantle cell lymphoma: bendamustine plus rituximab versus R-CHOP or R-CVP, with the standard regimen preassigned by the investigator, for 6 cycles (2 additional cycles permitted). Response assessed by a blinded independent review committee. Primary endpoint: complete response rate. 224 patients were randomised to bendamustine-rituximab and 223 to standard therapy.

Primary endpoint

CR rate

Arms

R-CHOP or R-CVP (control, n = 223): Rituximab with cyclophosphamide, vincristine and prednisone with or without doxorubicin (R-CVP or R-CHOP), 6 cycles
Bendamustine plus rituximab (experimental, n = 224): Bendamustine plus rituximab, 6 cycles

People

Flinn IW

Δ CR rate+6 pointsPFSHR 0.61 (95% CI 0.45–0.85)Δ 60-month PFS+9.7 points

Show the numbers

Results reported for BRIGHT
Endpoint	Analysis	Bendamustine plus rituximab	R-CHOP or R-CVP	Effect
CR rateNot labelled in the abstract	primaryFlinn 2014	31%	25%	P=0.0225P value is for non-inferiority (margin 0.88). Overall response rates were 97% and 91% (P=0.0102). Independent review committee assessment.
PFSNot labelled in the abstract	long term-updateFlinn 2019	65.5% at 5 y	55.8% at 5 y	HR 0.61 (95% CI 0.45–0.85)P=0.0025Investigator-assessed, minimum 5 years of monitoring after the end of study treatment; medians were not reached. Overall survival did not differ significantly.

Results reported for BRIGHT
Endpoint	Analysis	Bendamustine plus rituximab	R-CHOP or R-CVP	Effect
CR rateNot labelled in the abstract	primaryFlinn 2014	31%	25%	P=0.0225P value is for non-inferiority (margin 0.88). Overall response rates were 97% and 91% (P=0.0102). Independent review committee assessment.
PFSNot labelled in the abstract	long term-updateFlinn 2019	65.5% at 5 y	55.8% at 5 y	HR 0.61 (95% CI 0.45–0.85)P=0.0025Investigator-assessed, minimum 5 years of monitoring after the end of study treatment; medians were not reached. Overall survival did not differ significantly.

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
PFS	0.61	0.45–0.85

Appears in

2013 StiL: bendamustine-rituximab vs R-CHOP, first-line indolent/MCL

Sources

Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, et al. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014;123(19):2944-52.
PubMed DOI
Flinn IW, van der Jagt R, Kahl B, Wood P, Hawkins T, MacDonald D, et al. First-Line Treatment of Patients With Indolent Non-Hodgkin Lymphoma or Mantle-Cell Lymphoma With Bendamustine Plus Rituximab Versus R-CHOP or R-CVP: Results of the BRIGHT 5-Year Follow-Up Study. J Clin Oncol. 2019;37(12):984-991.
PubMed DOI