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NCT00553644 · ClinicalTrials.gov registry record · Phase 2

Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

A Phase 2 study of Recurrent Mantle Cell Lymphoma, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
53
Enrollment target
20
Study locations

NCT00553644: Completed Phase 2 study of Recurrent Mantle Cell Lymphoma, sponsored by National Cancer Institute (NCI).

NCT00553644 is a Phase 2 study of Recurrent Mantle Cell Lymphoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 53 participants, above the 36-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00553644, a Phase 2 study of Recurrent Mantle Cell Lymphoma, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
53 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial studies how well bortezomib and lenalidomide work in treating patients with mantle cell lymphoma that has come back after a period of improvement (refractory) or is not responding to treatment (refractory). Bortezomib may also stop the growth of cancer cells by blocking some proteins needed for cell growth. Lenalidomide may stimulate the immune system to kill cancer cells and may also block the growth of new blood vessels necessary for cell growth. Giving bortezomib with lenalidomide may be an effective treatment for relapsed or refractory mantle cell lymphoma.

Primary Outcome

Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a \>/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.

Conditions Studied

Recurrent Mantle Cell Lymphoma

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Lenalidomide
  • DRUG Bortezomib

Study Locations (20)

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Kaiser Permanente-Baldwin Park - Baldwin Park
  • Kaiser Permanente-Bellflower - Bellflower
  • Kaiser Permanente-Fontana - Fontana
  • Kaiser Permanente - Harbor City - Harbor City
  • Kaiser Permanente-Irvine - Irvine
  • Kaiser Permanente Los Angeles Medical Center - Los Angeles
  • Kaiser Permanente-Cadillac - Los Angeles
  • Kaiser Permanente - Panorama City - Panorama City
  • Kaiser Permanente-Riverside - Riverside
  • Kaiser Permanente-San Diego Mission - San Diego
  • Kaiser Permanente-San Diego Zion - San Diego
  • Kaiser Permanente-San Marcos - San Marcos
  • Kaiser Permanente-Woodland Hills - Woodland Hills

Delaware

  • Beebe Medical Center - Lewes
  • Christiana Care Health System-Christiana Hospital - Newark

Illinois

  • Graham Hospital Association - Canton
  • Memorial Hospital - Carthage

Connecticut

  • Hartford Hospital - Hartford

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2007-11-15
Est. Completion 2014-01-21
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00553644 record still lists

NCT00553644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, above the 36-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target (47% higher).

The record links to 1 condition, with Recurrent Mantle Cell Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT00553644 names 20 study sites across 5 states, led by California, Delaware, Illinois.

Frequently Asked Questions

What is clinical trial NCT00553644 about?

NCT00553644 is a clinical study titled "Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma". This phase II trial studies how well bortezomib and lenalidomide work in treating patients with mantle cell lymphoma that has come back after a period of improvement (refractory) or is not responding to treatment (refractory). Bortezomib may also stop the growth of cancer cells by blocking some prot...

What is the current status of trial NCT00553644?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2007-11-15. Estimated completion is 2014-01-21.

What conditions does trial NCT00553644 study?

This clinical trial studies the following conditions: Recurrent Mantle Cell Lymphoma.

What interventions are being tested in trial NCT00553644?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Lenalidomide (DRUG), Bortezomib (DRUG).

Who is sponsoring clinical trial NCT00553644?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00553644 being conducted?

This trial has 20 study locations across California, Connecticut, Delaware, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Recurrent 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 NCT00553644's enrollment target sits among peer trials

53 4th of 27 higher than 23 of 27 other Recurrent Mantle Cell Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent 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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Related registry views

Source: ClinicalTrials.gov NCT00553644, the US trial registry maintained by the National Library of Medicine. NCT00553644 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.