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NCT00722137 · ClinicalTrials.gov registry record · Phase 3

Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma

A Phase 3 study, sponsored by Millennium Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
487
Enrollment target

NCT00722137: Completed Phase 3 study, sponsored by Millennium Pharmaceuticals.

NCT00722137 is a Phase 3 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 487 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00722137, a Phase 3 study, has completed, sponsored by Millennium Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
487 participants
Enrollment target

Study Summary

This is a randomized, open-label, multicenter, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in participants who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation.

Primary Outcome

PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee.

Interventions

  • DRUG Rituximab 375 mg/m^2
  • DRUG Cyclophosphamide 750 mg/m^2
  • DRUG Doxorubicin 50 mg/m^2
  • DRUG VELCADE 1.3 mg/m^2
  • DRUG Prednisone 100 mg/m^2

Trial Details

FieldValue
Enrollment Target 487 participants
Start Date 2008-05-01
Est. Completion 2017-06-17
Phase Phase 3
Millennium Pharmaceuticals

135 total trials

What the finished NCT00722137 record still lists

NCT00722137 is an interventional study that assigns participants to a tested intervention. The registered 487 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).

The record links to 0 conditions, and to 5 interventions - of which Rituximab 375 mg/m^2 is the first listed.

NCT00722137 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00722137 about?

NCT00722137 is a clinical study titled "Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma". This is a randomized, open-label, multicenter, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in participants who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation.

What is the current status of trial NCT00722137?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 487 participants. The study started on 2008-05-01. Estimated completion is 2017-06-17.

What interventions are being tested in trial NCT00722137?

The interventions under investigation include: Rituximab 375 mg/m^2 (DRUG), Cyclophosphamide 750 mg/m^2 (DRUG), Doxorubicin 50 mg/m^2 (DRUG), VELCADE 1.3 mg/m^2 (DRUG), Prednisone 100 mg/m^2 (DRUG).

Who is sponsoring clinical trial NCT00722137?

This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00722137's enrollment target sits among peer trials

487 786th of 2000 higher than 1,212 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00722137, the US trial registry maintained by the National Library of Medicine. NCT00722137 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.