CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 224 enrolled
Drug / intervention
Autologous transplantation using rituxan/BEAM +1 moredrug
Likely dose
Autologous transplantation using rituxan/BEAM 375 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00329030
NCT00329030Phase 3Completed
CompareCT.gov

Phase III Rituxan/BEAM vs. Bexxar/BEAM With Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-cell Non-Hodgkin's Lymphoma (BMTCTN0401)

National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted May 24, 2006·Updated Nov 1, 2021

In Brief

A Phase 3 clinical trial evaluating Autologous transplantation using rituxan/BEAM and Autologous transplantation using Bexxar/BEAM for Lymphoma, B-Cell and 2 related conditions. Completed, enrolled 224 participants across 36 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, B-Cell, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Non-Hodgkin
CountriesUnited States
CollaboratorsBlood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 24, 2006
Enrollment StartDec 1, 2005
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 20.1 years ago

Interventions

Autologous transplantation using rituxan/BEAMdrug

Rituxan 375 mg/m2 (Day -19 and Day -12); BCNU 300 mg/m2 (Day -6); Etoposide (VP-16) 100 mg/m2 twice a day (Days -5 to -2); Cytarabine 100 mg/m2 twice a day (Days -5 to -2); Melphalan 140 mg/m2 (Day -1); Followed by autologous transplantation

Autologous transplantation using Bexxar/BEAMdrug

Bexxar dosimetric dose 5 mCi (Day -19); Bexxar therapy dose 75 cGy TBD (Day -12); BCNU 300 mg/m2 (Day -6); Etoposide (VP-16) 100 mg/m2 twice a day (Days -5 to -2); Cytarabine 100 mg/m2 twice a day (Days -5 to -2); Melphalan 140 mg/m2 (Day -1); Followed by autologous transplantation