Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma
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.
1 other identifier
interventional
93
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2004
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 14, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedAugust 13, 2012
August 1, 2012
2.8 years
October 14, 2005
August 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Rate
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.
Week 26
Secondary Outcomes (7)
Complete response rate (CR)
From the start of treatment (Study Day 0, Baseline) until long-term follow-up (every 6 months until 5 years from the time of study entry)
Duration of response
5 years
Progression-free survival (PFS)
5 years or until death
Adverse events
5 years or until death
Quality of Life
5 Years
- +2 more secondary outcomes
Study Arms (1)
Arm 1
EXPERIMENTALParticipants underwent two phases of treatment: an initial DD, followed by a therapeutic dose. The one-day DD comprised a 1 hr IV infusion of 450 mg unlabeled TST, followed by a 20 min IV infusion of 35 mg TST labeled with 185 MBq (5.0 mCi) of I 131. After 7 to 14 days, the one-day therapeutic dose comprised a second 1 hr IV infusion of 450 mg unlabeled TST, followed by a 20 min IV infusion of 35 mg TST labeled with I 131 with an administered activity (MBq or mCi) determined from the dosimetry calculation.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (11)
GSK Investigational Site
Calgary, Alberta, T2N 4N2, Canada
GSK Investigational Site
Edmonton, Alberta, T6G 1Z2, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3H 2Y9, Canada
GSK Investigational Site
Hamilton, Ontario, L8V 5C2, Canada
GSK Investigational Site
Ottawa, Ontario, K1H 8L6, Canada
GSK Investigational Site
Toronto, Ontario, M4N 3M5, Canada
GSK Investigational Site
Toronto, Ontario, M5G 2M9, Canada
GSK Investigational Site
Montreal, Quebec, H2L 4M1, Canada
GSK Investigational Site
Montreal, Quebec, H4J 1C5, Canada
GSK Investigational Site
Québec, Quebec, G1R 2J6, Canada
GSK Investigational Site
Québec, Quebec, G1S 4L8, Canada
Related Publications (1)
Olney HJ, Freeman MA, Stewart DA, Mangel JE, White DJ, Elia-Pacitti JO. Prolonged progression-free survival and preserved quality of life in the Canadian prospective study of tositumomab and iodine(131)-tositumomab for previously treated, rituximab-exposed, indolent non-Hodgkin lymphoma. Leuk Lymphoma. 2014 Dec;55(12):2754-60. doi: 10.3109/10428194.2014.894190. Epub 2014 Apr 3.
PMID: 24528219DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2005
First Posted
October 18, 2005
Study Start
April 1, 2004
Primary Completion
February 1, 2007
Study Completion
September 1, 2011
Last Updated
August 13, 2012
Record last verified: 2012-08