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NCT00294632 · ClinicalTrials.gov registry record · Phase 1

Lenalidomide and Rituximab in the Treatment of Relapsed Mantle Cell Lymphoma (MCL) and Diffuse Large B-Cell Lymphoma

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
54
Enrollment target

NCT00294632: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT00294632 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00294632, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
54 participants
Enrollment target

Study Summary

The goal of this clinical research study is to find the highest tolerable dose of the drug lenalidomide (Revlimid, lenalidomide) that can be given with Rituxan® (rituximab) in the treatment of relapsed mantle cell lymphoma. The safety and effectiveness of this combination treatment will also be studied in both mantle cell lymphoma and diffuse large B-cell non-Hodgkin's lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma).

Primary Outcome

MTD is defined as the highest dose level in which 1 or fewer participants experienced a dose limiting toxicity (DLT) in 6 participants treated. DLT is any grade III or IV toxicity during the first 28 days (first cycle) of therapy.

Interventions

  • DRUG Rituximab
  • DRUG Lenalidomide

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2006-02
Est. Completion 2016-02
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00294632 record still lists

NCT00294632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).

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

NCT00294632 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00294632 about?

NCT00294632 is a clinical study titled "Lenalidomide and Rituximab in the Treatment of Relapsed Mantle Cell Lymphoma (MCL) and Diffuse Large B-Cell Lymphoma". The goal of this clinical research study is to find the highest tolerable dose of the drug lenalidomide (Revlimid, lenalidomide) that can be given with Rituxan® (rituximab) in the treatment of relapsed mantle cell lymphoma. The safety and effectiveness of this combination treatment will also be stud...

What is the current status of trial NCT00294632?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2006-02. Estimated completion is 2016-02.

What interventions are being tested in trial NCT00294632?

The interventions under investigation include: Rituximab (DRUG), Lenalidomide (DRUG).

Who is sponsoring clinical trial NCT00294632?

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 NCT00294632's enrollment target sits among peer trials

54 931st of 2000 higher than 1,053 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00294632, the US trial registry maintained by the National Library of Medicine. NCT00294632 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.