A Single Arm, Open-label, Multicentre, Phase II Study of Tositumomab and Iodine 131-Tositumomab in Subjects With Indolent Non-Hodgkin's Lymphoma Who Have Previously Received Rituximab.
18 Years
N/A
Both
Lymphoma, Non-Hodgkin
Trial Information
A Single Arm, Open-label, Multicentre, Phase II Study of Tositumomab and Iodine 131-Tositumomab in Subjects With Indolent Non-Hodgkin's Lymphoma Who Have Previously Received Rituximab.
Inclusion Criteria
Inclusion criteria:
- Patients must have evidence of persistent or progressive follicular grade, 1, 2 or 3
or marginal zone B-cell non-Hodgkin's lymphoma.
- Must have received at least two prior courses of systemic treatment including at
least one treatment of rituximab (lymphoma must not have progressed during their most
recent systemic chemotherapy treatment).
- Must have evidence that their lymphoma expresses CD20 antigen and have adequate renal
and hepatic function.
Exclusion criteria:
- Received chemotherapy, radiation therapy, immunosuppressants or cytokine treatment
within 4 weeks prior to study entry.
- Have active obstructive hydronephrosis.
- Had prior autologous hematopoietic stem cell transplant or any allogenic stem cell
transplant.
- Have active infection requiring IV antibiotics.
- Have brain or leptomeningeal metastasis.
- Had previous allergic reaction to iodine, previously received radioimmunotherapy or
are currently receiving approved or experimental anti-cancer drugs.
- Patients who are pregnant or breast feeding, have known HIV infection, or are Human
anti-murine antibody (HAMA) positive.
- Other criteria will be evaluated at the screening visit.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response Rate
Outcome Description:
Responders are defined as participants with Complete Response (CR: disappearance of all clinical and radiological evidence of lymphoma), Clinical Complete Response (CCR: all criteria met for CR, except there is a residual nodal mass >15 millimeters), or Partial Response (PR: 50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions). Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation.
Outcome Time Frame:
Week 26
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Canada: Health Canada
Study ID:
393229/032
NCT ID:
NCT00240565
Start Date:
April 2004
Completion Date:
September 2011
Related Keywords:
- Lymphoma, Non-Hodgkin
- BEXXAR
- non-Hodgkin's Lymphoma
- tositumomab
- I-131
- Lymphoma
- Lymphoma, Non-Hodgkin
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