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NCT00609869 · ClinicalTrials.gov registry record · Phase 2

Lenalidomide in Comb w/Rituximab for Pts w/CD5+/CD20+ Hem Malignancies Who Relapse/Progress After Rituximab

A Phase 2 study of Mantle Cell Lymphoma and Lymphocytic Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 2
Development phase
29
Enrollment target
2
Study locations

NCT00609869: Completed Phase 2 study of Mantle Cell Lymphoma and Lymphocytic Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT00609869 is a Phase 2 study of Mantle Cell Lymphoma and Lymphocytic Leukemia that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 29 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (72% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00609869, a Phase 2 study of Mantle Cell Lymphoma and Lymphocytic Leukemia, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 2
Development phase
29 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this research is to evaluate the use of Rituximab in combination with Revlimid in the treatment of refractory Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL). Revlimid® is a drug that changes the immune system and it may also get in the way with the growth of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Revlimid® is approved by the Food and Drug Administration (FDA) for the treatment of specific types of Myelodysplasia syndrome (MDS) and Multiple Myeloma, two different types of blood cancer. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.

Primary Outcome

The sum of Complete Remission (CR) plus Partial Remission (PR) rates. Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, and must be confirmed greater than 8 weeks after first meeting CR or PR criteria. Response and progression for Chronic Lymphocytic Leukemia (CLL) were evaluated using 2008 updated National Cancer Institute-Sponsored W

Interventions

  • DRUG Rituximab
  • DRUG Lenalidomide

Study Locations (2)

Florida

  • Center for Cancer Care & Research/Watson - Lakeland
  • H. Lee Moffitt Cancer Center and Research Institute - Tampa

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2007-10
Est. Completion 2015-08
Phase Phase 2

What the finished NCT00609869 record still lists

NCT00609869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (72% lower).

The record links to 2 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Rituximab is the first listed.

NCT00609869 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT00609869 about?

NCT00609869 is a clinical study titled "Lenalidomide in Comb w/Rituximab for Pts w/CD5+/CD20+ Hem Malignancies Who Relapse/Progress After Rituximab". The purpose of this research is to evaluate the use of Rituximab in combination with Revlimid in the treatment of refractory Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL). Revlimid® is a drug that changes the immune system and it may also get in the way with the growth of tiny bl...

What is the current status of trial NCT00609869?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2007-10. Estimated completion is 2015-08.

What conditions does trial NCT00609869 study?

This clinical trial studies the following conditions: Mantle Cell Lymphoma, Lymphocytic Leukemia.

What interventions are being tested in trial NCT00609869?

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

Who is sponsoring clinical trial NCT00609869?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00609869 being conducted?

This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Mantle Cell Lymphoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00609869's enrollment target sits among peer trials

29 69th of 102 higher than 34 of 102 other Mantle Cell Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Mantle Cell Lymphoma 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 NCT00609869, the US trial registry maintained by the National Library of Medicine. NCT00609869 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.