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NCT00376961 · ClinicalTrials.gov registry record · Phase 2

S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

A Phase 2 study, sponsored by SWOG Cancer Research Network.

Completed
Registry status
Phase 2
Development phase
68
Enrollment target

NCT00376961: Completed Phase 2 study, sponsored by SWOG Cancer Research Network.

NCT00376961 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00376961, a Phase 2 study, has completed, sponsored by SWOG Cancer Research Network.

COMPLETED
Registry status
Phase 2
Development phase
68 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. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the cancer from progressing. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib followed by bortezomib alone works in treating patients with newly diagnosed mantle cell lymphoma.

Primary Outcome

Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause.

Interventions

  • DRUG prednisone
  • DRUG cyclophosphamide
  • BIOLOGICAL rituximab
  • DRUG doxorubicin hydrochloride
  • DRUG bortezomib

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2006-08
Est. Completion 2017-09
Phase Phase 2
SWOG Cancer Research Network

270 total trials

What the finished NCT00376961 record still lists

NCT00376961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).

The record links to 0 conditions, and to 5 interventions - of which prednisone is the first listed.

NCT00376961 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00376961 about?

NCT00376961 is a clinical study titled "S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle 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. Drugs used in chemotherapy work in different ways to stop...

What is the current status of trial NCT00376961?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2006-08. Estimated completion is 2017-09.

What interventions are being tested in trial NCT00376961?

The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), rituximab (BIOLOGICAL), doxorubicin hydrochloride (DRUG), bortezomib (DRUG).

Who is sponsoring clinical trial NCT00376961?

This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00376961's enrollment target sits among peer trials

68 967th of 2000 higher than 1,027 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 NCT00376961, the US trial registry maintained by the National Library of Medicine. NCT00376961 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.