Phase 2 Study of Bexxar in Relapsed/Refractory DLCL
3 other identifiers
interventional
9
1 country
1
Brief Summary
The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 lymphoma
Started Sep 2004
Typical duration for phase_2 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 20, 2007
CompletedFirst Posted
Study publicly available on registry
June 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
February 28, 2017
CompletedMarch 30, 2017
February 1, 2017
5.6 years
June 20, 2007
January 9, 2017
February 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Response Rate
Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.
6 years
Secondary Outcomes (2)
Time to Progression (TTP)
1.5 months; 3 months; 6 months; or Not Progressed
Overall Survival (OS) Rate
6 years
Study Arms (1)
Bexxar + Total Body Irradiation (TBI)
EXPERIMENTALBexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI).
Interventions
Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. The radioactive isotope then gives off radiation, which kills the cells. Bexxar will be administered to provide the following patient-specific radiotherapy: * Platelet count of 150,000/mm³ = 75 cGy * Platelet count ≥ 100,000/mm³ but \< 150,000/mm³ = 65 cGy
As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain
As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions
Administered to prevent thyroid blockage 130 mg orally 3 times a day,
Eligibility Criteria
You may qualify if:
- Histologically-confirmed, diffuse large cell lymphoma (DLCL), CD20+ B-cell non-Hodgkin lymphoma (NHL) who have relapsed after chemotherapy or are chemotherapy resistant, without prior history of low grade NHL. The patient must have failed at least one chemotherapy regimen containing an anthracycline or equivalent chemotherapeutic agent.
- No anticancer treatment for three weeks prior to the treatment dose of Bexxar (6 weeks if Rituximab, nitrosourea or Mitomycin C)
- Fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy
- An Institutional Review Board (IRB)-approved signed informed consent
- Age 19 years or older
- Prestudy Karnofsky Performance Status of ≥ 70%
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hct \> 30%
- Hgb \> 9.0 gm%
- Bilirubin ≤ 2.0
- Creatinine ≤ 2.0
- Bone marrow involvement with lymphoma less than 25% (bilateral bone marrow) within 6 weeks of enrollment
- Acceptable birth control method for men and women
- Female patients who are not pregnant
- +1 more criteria
You may not qualify if:
- Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
- Platelet count \< 100,000/mm³
- Hypocellular bone marrow (≤ 15% cellularity)
- Marked reduction in bone marrow precursors of one or more cell lines
- History of failed stem cell collection
- Prior treatment with Fludarabine
- Prior radioimmunotherapy
- Presence of central nervous system (CNS) lymphoma
- Patients with known HIV or AIDS-related lymphoma
- Patients with evidence of myelodysplasia on bone marrow biopsy
- Patients who have received prior external beam radiation therapy to more than 25% of active bone marrow
- Patients who have received filgrastim or sargramostim therapy within 3 weeks prior to treatment
- Pregnant
- Lactating
- Presence of human anti-mouse antibody (HAMA) reactivity in patients with prior exposure to murine antibodies or proteins
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Susan Knoxlead
- Corixa Corporationcollaborator
- GlaxoSmithKlinecollaborator
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susan J Knox, MD, Associate Professor of Radiation Oncology
- Organization
- Stanford University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Susan J Knox
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 20, 2007
First Posted
June 22, 2007
Study Start
September 1, 2004
Primary Completion
April 1, 2010
Study Completion
June 1, 2013
Last Updated
March 30, 2017
Results First Posted
February 28, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share