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NCT00329030 · ClinicalTrials.gov registry record · Phase 3

Rituxan/BEAM vs Bexxar/BEAM in Autologous Hematopoietic Stem Cell Transplant for Non-Hodgkin's Lymphoma (BMTCTN0401)

A Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Completed
Registry status
Phase 3
Development phase
224
Enrollment target

NCT00329030: Completed Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

NCT00329030 is a Phase 3 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 224 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00329030, a Phase 3 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

COMPLETED
Registry status
Phase 3
Development phase
224 participants
Enrollment target

Study Summary

This study is designed as a Phase III, multicenter trial, comparing progression-free survival (PFS) after autologous hematopoietic stem cell transplantation using a standard Rituxan plus BEAM transplant regimen versus a regimen adding Bexxar to BEAM.

Primary Outcome

Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (\> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first.

Interventions

  • DRUG Autologous transplantation using rituxan/BEAM
  • DRUG Autologous transplantation using Bexxar/BEAM

Trial Details

FieldValue
Enrollment Target 224 participants
Start Date 2005-12
Est. Completion 2013-08
Phase Phase 3

What the finished NCT00329030 record still lists

NCT00329030 is an interventional study that assigns participants to a tested intervention. The registered 224 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 (71% lower).

The record links to 0 conditions, and to 2 interventions - of which Autologous transplantation using rituxan/BEAM is the first listed.

NCT00329030 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00329030 about?

NCT00329030 is a clinical study titled "Rituxan/BEAM vs Bexxar/BEAM in Autologous Hematopoietic Stem Cell Transplant for Non-Hodgkin's Lymphoma (BMTCTN0401)". This study is designed as a Phase III, multicenter trial, comparing progression-free survival (PFS) after autologous hematopoietic stem cell transplantation using a standard Rituxan plus BEAM transplant regimen versus a regimen adding Bexxar to BEAM.

What is the current status of trial NCT00329030?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 224 participants. The study started on 2005-12. Estimated completion is 2013-08.

What interventions are being tested in trial NCT00329030?

The interventions under investigation include: Autologous transplantation using rituxan/BEAM (DRUG), Autologous transplantation using Bexxar/BEAM (DRUG).

Who is sponsoring clinical trial NCT00329030?

This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00329030's enrollment target sits among peer trials

224 1317th of 2000 higher than 684 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 NCT00329030, the US trial registry maintained by the National Library of Medicine. NCT00329030 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.