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NCT00411086 · ClinicalTrials.gov registry record · Phase 2

Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target

NCT00411086: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00411086 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00411086, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target

Study Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell lymphoma. PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with GM-CSF works in treating patients with newly diagnosed follicular B-cell lymphoma.

Primary Outcome

Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities \[e.g., lactate dehydrogenase (LDH)\] definitely assignable to NHL. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.

Interventions

  • BIOLOGICAL Rituximab
  • BIOLOGICAL Sargramostim (GM-CSF)

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2006-11
Est. Completion 2016-11
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00411086 record still lists

NCT00411086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.

NCT00411086 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00411086 about?

NCT00411086 is a clinical study titled "Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma". RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase ...

What is the current status of trial NCT00411086?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2006-11. Estimated completion is 2016-11.

What interventions are being tested in trial NCT00411086?

The interventions under investigation include: Rituximab (BIOLOGICAL), Sargramostim (GM-CSF) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00411086?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00411086's enrollment target sits among peer trials

60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00411086, the US trial registry maintained by the National Library of Medicine. NCT00411086 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.