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NCT00075946 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Eastern Cooperative Oncology Group.

Completed
Registry status
Phase 3
Development phase
545
Enrollment target

NCT00075946: Completed Phase 3 study, sponsored by Eastern Cooperative Oncology Group.

NCT00075946 is a Phase 3 study that has completed, run by Eastern Cooperative Oncology Group. The registered enrollment target is 545 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00075946, a Phase 3 study, has completed, sponsored by Eastern Cooperative Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
545 participants
Enrollment target

Study Summary

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.

Primary Outcome

TTRF is defined as the time from randomization until any one of the following criteria are met, and censored at last disease assessment for cases who have not experienced failure (with the cut-off date for final analysis of 11/1/2011): 1. No response (partial response (PR) or complete response (CR)) to rituximab retreatment (Arm A treatment). 2. Time to progression \< 26 weeks from day 1 of most recent rituximab treatment. 3. Initiation of alternative therapy. 4. Inability to complete protocol t

Interventions

  • BIOLOGICAL rituximab

Trial Details

FieldValue
Enrollment Target 545 participants
Start Date 2004-01-23
Est. Completion 2021-08
Phase Phase 3
Eastern Cooperative Oncology Group

141 total trials

What the finished NCT00075946 record still lists

NCT00075946 is an interventional study that assigns participants to a tested intervention. The registered 545 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower).

The record links to 0 conditions, and to 1 intervention - of which rituximab is the first listed.

NCT00075946 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00075946 about?

NCT00075946 is a clinical study titled "Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma". 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 randomi...

What is the current status of trial NCT00075946?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 545 participants. The study started on 2004-01-23. Estimated completion is 2021-08.

What interventions are being tested in trial NCT00075946?

The interventions under investigation include: rituximab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00075946?

This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00075946's enrollment target sits among peer trials

545 689th of 2000 higher than 1,310 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00075946, the US trial registry maintained by the National Library of Medicine. NCT00075946 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.