Rituxan/BEAM vs Bexxar/BEAM in Autologous Hematopoietic Stem Cell Transplant for Non-Hodgkin's Lymphoma (BMTCTN0401)
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)
4 other identifiers
interventional
224
1 country
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2005
Longer than P75 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 22, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
June 10, 2016
CompletedNovember 1, 2021
August 1, 2017
7.7 years
May 22, 2006
January 28, 2016
October 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
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.
1 and 2 years
Secondary Outcomes (11)
Overall Survival
1 and 2 years
Incidence of Relapse/Progression
1 and 2 years
Complete Response (CR) and Partial Response (PR) Proportion
Day 100 and 2 years
Platelet Recovery to 20,000 Cells/μL
100 and 180 days
Hematologic Function
100 days, 1 year
- +6 more secondary outcomes
Study Arms (2)
Rituxan/BEAM
ACTIVE COMPARATORAutologous transplantation using rituxan/BEAM
Bexxar/BEAM
EXPERIMENTALAutologous transplantation using Bexxar/BEAM
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Diagnosis of persistent or recurrent REAL classification diffuse large B-cell lymphoma, composite lymphoma with more than 50% diffuse large B-cell lymphoma, mediastinal B-cell lymphoma
- Demonstration of CD20+ on at least one histologic specimen
- years old at time of first registration
- Three or fewer prior regimens of chemotherapy over the entire course of their disease treatment (including one induction chemotherapy and no more than 2 salvage chemotherapies); monoclonal antibody therapy and involved field radiation therapy will not be counted as prior therapies
- Disease status of primary induction failure, first relapse, or second complete remission; all patients must have chemosensitive disease as demonstrated by response to induction or salvage chemotherapy with at least a partial response (as defined in the protocol)
- No more than a 20% bone marrow involvement
- Patients with adequate organ function as measured by:
- Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity; ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; additionally, patients greater than 60 years of age must have a left ventricular ejection fraction at rest of at least 40% demonstrated by Multi-Gated Acquisition Scan (MUGA)
- Hepatic: Bilirubin less than 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome) and alanine transaminase (ALT) and aspartate transaminase (AST) less than 3x the upper limit of normal
- Renal: Creatinine less than 2.0 mg/dL or creatinine clearance (calculated creatinine clearance is permitted) more than 40 mL/min; no hydronephrosis on CT scan prior to mobilization
- Pulmonary: Carbon Monoxide Diffusing Capacity (DLCO), Volume forcibly exhaled in one second (FEV1), forced vital capacity (FVC) at least 45% of predicted (corrected for hemoglobin)
- Autologous graft with a minimum of at least 1.5 X 10\^6 CD34+ cells/kg (target greater than 2.0 X 10\^6 CD34+ cells/kg. Peripheral blood stem cells (PBSC) are preferred; however, if PBSC mobilization fails, cells can be obtained by institutional practices (in cases where bone marrow will be used for transplantation, the required CD34+ dose does not apply and institutional practice for total nucleated cell dose should be used).
- Initiate conditioning therapy within 3 months of mobilization
- Signed informed consent
You may not qualify if:
- Karnofsky performance score less than 70%
- Transformed follicular lymphoma
- Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
- Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Medical Monitor or Protocol Chair; cancer treated with curative intent less than 5 years previously will be allowed
- Pregnant (positive β-HCG) or breastfeeding; this patient population is excluded due to the lack of data on the use of Bexxar in patients who are pregnant or breastfeeding
- Seropositivity for HIV; this patient population is excluded due to the lack of data on the use of Bexxar in HIV positive patients and because the treatment regimens are too immunosuppressive for this patient population
- Fertile men or women unwilling to use contraceptive techniques from the time of initiation of mobilization until six-months post-transplant
- Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT)
- Patients with evidence of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) or abnormal cytogenetic analysis indicative of MDS on the pre-transplant bone marrow examination
- Patients with a prior severe reaction to Rituxan or Filgrastim (G-CSF). Patients with severe reactions to G-CSF that receive pre-medication for control of the reaction are not excluded from study.
- Patients who have received prior radioimmunotherapy
- Patients with known hypersensitivity to murine proteins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
University of Florida College of Medicine (Shands)
Gainesville, Florida, 32610, United States
University of Miami
Miami, Florida, 33136, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33624, United States
Emory University
Atlanta, Georgia, 30322, United States
St. Lukes Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Maryland Medical Systems/Greenbaum Cancer Center
Baltimore, Maryland, 21228, United States
Johns Hopkins/SKCCC
Baltimore, Maryland, 21231, United States
Tufts-New England Medical Center
Boston, Massachusetts, 02111, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Weill Cornell Medical College, The New York Presbyterian Hospital
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina Hospital at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, 44106, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Columbia River Oncology Program
Portland, Oregon, 97225, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
University of Utah Medical School, BMT
Salt Lake City, Utah, 84132, United States
Intermountain BMT Program
Salt Lake City, Utah, 84143, United States
Virginia Commonwealth University/MCV Hospital
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53211, United States
Related Publications (1)
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.
PMID: 23478060RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam Mendizabal
- Organization
- The EMMES Corporation
Study Officials
- STUDY DIRECTOR
Mary Horowitz, MD
Center for International Blood and Marrow Transplant Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2006
First Posted
May 24, 2006
Study Start
December 1, 2005
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
November 1, 2021
Results First Posted
June 10, 2016
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Within 6 months of official study closure at participating sites.
- Access Criteria
- Available to the public
Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).