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

Phase 3 Completed 224 enrolled National Heart, Lung, and Blood Institute (NHLBI) Blood and Marrow Transplant Clinical Trials Network · collab National Cancer Institute (NCI) · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2005-12
Primary completion: 2013-08
Completion: 2013-08

Outcome

Missed primary endpoint

paper the primary end point, were 48.6% (95% CI, 38.6% to 57.8%) for R-BEAM and 47.9% (95% CI, 38.2% to 57%; P = .94) for B-BEAM PMID 23478060 ↗

Publications

Results Vose JM, Carter S, Burns LJ, Ayala E, Press OW, Moskowitz CH, Stadtmauer EA, Mineshi S, Ambinder R, Fenske T, Horowitz M, Fisher R, Tomblyn M. Phase III randomized study of rituximab/carmustine, etoposide, cytarabine, and melphalan (BEAM) compared with iodine-131 tositumomab/BEAM with autologous hematopoietic cell transplantation for relapsed diffuse large B-cell lymphoma: results from the BMT CTN 0401 trial. J Clin Oncol. 2013 May 1;31(13):1662-8. doi: 10.1200/JCO.2012.45.9453. Epub 2013 Mar 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Subject	TOSITUMOMAB 131I	Monoclonal antibody	75 unknown	—
Comparator	Cytarabine	Small molecule	100 mg/m2	—
Comparator	Etoposide	Small molecule	100 mg/m2	—
Comparator	Melphalan	Small molecule	140 mg/m2	—
Comparator	carmustine	Small molecule	300 mg/m2	—