Last updated: 11/07/2018 16:13:31
Expanded access study of Iodine-131 anti-B1 antibody for relapsed/refractory low-grade and transformed low-grade non-Hodgkin’s lymphoma
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Expanded access study of Iodine-131 anti-B1 antibody for relapsed/refractory low-grade and transformed low-grade non-Hodgkin’s lymphoma
Trial description: Expanded access study of Iodine-131 anti-B1 antibody for relapsed/refractory low-grade and transformed low-grade non-Hodgkin’s lymphoma
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Dillman RO, Hurwitz RR, Lyons KK, et al. Expanded access experience with anti-CD20 radiolabeled monoclonal antibodies for the treatment of B-cell lymphoma. Blood 2000: 96 (suppl, pt 2) 236b. Abstract 4751.
Gockerman J, Gregory S, Harwood S, et al. Interim efficacy results of Bexxar in a large multicenter expanded access study. Proc Am Soc Clin Oncol 2001: 20 (pt 1) 285a. Abstract 1137.
Gregory SA, Leonard J, Coleman M, Fehrenbacher L, Bhatnagar A, Magnuson D, et al. Bexxar (tositumomab, iodine I 131 tositumomab) can be safely administered in relapsed low-grade or transformed low-grade non-Hodgkin’s lymphoma (NHL) patients after prior treatment with rituximab: initial experience from the expanded access study. Blood 1999: 94 (suppl 1, pt 1) 91a.
Kostakoglu L, Ali A, Coleman R, et al. Efficacy and safety of Bexxar in a large multicenter expanded access study. J Nucl Med May 2001: 42 (suppl) 122. Abstract 455.
Leonard J, Frenette G, Dillman RO, et al. Interim safety and efficacy results of Bexxar in a large multicenter expanded access study. Blood 2001: 98 (pt 1) 133a. Abstract 559.
Schenkein DP, Leonard J, Harwood S, et al. Interim safety results of Bexxar in a large multicenter expanded access study. Proc Am Soc Clin Oncol 2001: 20 (pt 1) 285a. Abstract 1138.
Medical condition
Lymphoma, Non-Hodgkin
Product
tositumomab
Collaborators
Not applicable
Study date(s)
September 1998 to Invalid Date
Type
Not applicable
Phase
4
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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