Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• rituximab — BIOLOGICAL
  Given IV

Study Details

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and comparing them to see how well they work in treating patients with low tumor burden indolent stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's lymphoma.

Key Dates

Start date

Jan 23, 2004

Status verified

Jan 2024

Primary completion

Sep 30, 2013

Completion

Aug 31, 2021

Study Design

Enrollment

545 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A: Rituximab Retreatment
  Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
• Experimental: Arm B: Rituximab Scheduled
  Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.

Primary Outcome Measure

Time to Rituximab Failure (TTRF) [ Time Frame: Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first. ]

Locations (483)

Find similar trials in Scottsdale, AZ

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