Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With R-CVP or R-CHOP in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL) - Referred to as the BRIGHT Study

Conditions

• Mantle Cell Lymphoma
• Non-Hodgkin's Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bendamustine — DRUG
• rituximab — DRUG
• vincristine — DRUG
• prednisone — DRUG
• cyclophosphamide — DRUG
• doxorubicin — DRUG

Study Details

The primary objective of the study is to compare the complete response (CR) rate of bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with advanced, indolent non-Hodgkin's lymphoma (NHL) or mantle cell lymphoma (MCL).

Key Dates

Start date

Apr 30, 2009

Status verified

Jan 2018

Primary completion

Mar 31, 2012

Completion

Mar 31, 2012

Study Design

Enrollment

447 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bendamustine and Rituximab (BR)
  Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\^2 IV on Day 1
• Active Comparator: R-CHOP/R-CVP
  Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles. R-CHOP: rituximab 375 mg/m\^2 IV on Day 1; vincristine 1.4 mg/m\^2 (up to 2 mg/m\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\^2 IV Day 1; cyclophosphamide 750 mg/m\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5 R-CVP: rituximab 375 mg/m\^2 IV on Day 1; cyclophosphamide 750 mg/m\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\^2 IV on Day 1; vincristine 1.4 mg/m\^2 (up to 2 mg/m\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5

Primary Outcome Measure

Percentage of Participants With Complete Response (CR) at End of Treatment Period [ Time Frame: 6 to 8 21 or 28-day cycles (18-32 weeks) ]

Locations (79)

Find similar trials in Tucson, AZ

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