Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma, Non-Hodgkin
Intervention: Tositumomab (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
This study will further characterize the activity of Tositumomab and Iodine I 131-Tositumomab in patients with relapsed indolent non-Hodgkin's Lymphoma who have progressed following treatment with rituximab.
Clinical Details
Official title:
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.
Study design: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: Response Rate
Secondary outcome: Complete response rate, duration of response, progression-free survival, survival, Adverse events, Quality of Life, Resource utilization Assessment
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Edmonton, Alberta T6G 1Z2, Canada; Active, not recruiting
GSK Clinical Trials Call Center, Calgary, Alberta T2N 4N2, Canada; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Vancouver, British Columbia V5Z 4E6, Canada; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Halifax, Nova Scotia B3H 2Y9, Canada; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, London, Ontario N6A 4G5, Canada; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Hamilton, Ontario L8V 5C2, Canada; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Toronto, Ontario M5G 2M9, Canada; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Toronto, Ontario M4N 3M5, Canada; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Ottawa, Ontario K1H 8L6, Canada; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Montreal, Quebec H3A 1A1, Canada; Terminated
GSK Clinical Trials Call Center, Montreal, Quebec H2L 4M1, Canada; Active, not recruiting
GSK Clinical Trials Call Center, Montreal, Quebec H1T 2M4, Canada; Terminated
GSK Clinical Trials Call Center, Quebec City, Quebec G1R 2J6, Canada; Active, not recruiting
GSK Clinical Trials Call Center, Montreal, Quebec H4J 1C5, Canada; Active, not recruiting
GSK Clinical Trials Call Center, Quebec City, Quebec G1S 4L8, Canada; Active, not recruiting
Additional Information
Starting date:
April 2004
Last updated: September 13, 2007
|
