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

Completed · Phase 3

Conditions studied: Lymphoma, B-Cell, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID

NCT00329030

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

224

Starts

2005-12-01

Expected to finish

2013-08-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• 18-80 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

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Florida College of Medicine (Shands) — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• St. Lukes Mountain States Tumor Institute — Boise, Idaho, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Maryland Medical Systems/Greenbaum Cancer Center — Baltimore, Maryland, United States
• Johns Hopkins/SKCCC — Baltimore, Maryland, United States
• Tufts-New England Medical Center — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University/Barnes Jewish Hospital — St Louis, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical College, The New York Presbyterian Hospital — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• University of North Carolina Hospital at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals of Cleveland/Case Western — Cleveland, Ohio, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Columbia River Oncology Program — Portland, Oregon, United States
• University of Pennsylvania Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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