Last updated: 11/07/2018 14:21:16
Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Percentage of participants with confirmed objective response rate and investigator assessed best response at the end of the 26-week study
Timeframe: Up to Week 26
Secondary outcomes:
Percentage of participants with confirmed objective CR rate and investigator assessed CR rate
Timeframe: 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)
Summary of duration of response
Timeframe: Up to 5 years
Summary of progression-free survival (PFS)
Timeframe: Up to 5 years or until death
Summary of duration of overall survival
Timeframe: Up to 5 years or until death
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to Week 26
Change from Baseline (Screening, Day -21 to -1) in FACT-Lym Questionnaire (Quality of Life)
Timeframe: Baseline (Screening, Day -21 to -1) and Week 26
Resource Utilization Assessment-general health in last 7 days
Timeframe: Up to Week 26
Resource Utilization Assessment-lost productivity: number of participants with work for pay status changed in last 7 days
Timeframe: Up to Week 26
Resource Utilization Assessment-lost productivity: median work for pay hours missed and number of missed work hours
Timeframe: Up to Week 26
Resource Utilization Assessment-lost productivity: number of participants with reason for missed work in last 7 days
Timeframe: Up to Week 26
Resource Utilization Assessment- lost productivity: Number of participants with average time waited in waiting room of medical clinic
Timeframe: Up to Week 26
Resource Utilization Assessment-caregiver information: primary caregiver #1, 2, 3 since diagnosis
Timeframe: Up to Week 26
Resource Utilization Assessment-caregiver information: number of participants with caregiver #1, 2, 3 hours missed in last 7 days
Timeframe: Up to Week 26
Resource Utilization Assessment-caregiver information: caregiver #1, 2, 3 - work for pay hours missed
Timeframe: Up to Week 26
Resource Utilization Assessment-caregiver information: required paid healthcare worker in last 7 days
Timeframe: Up to Week 26
Resource Utilization Assessment-caregiver information: total number of hours paid healthcare worker spent with participant
Timeframe: Up to Week 26
Interventions:
Drug: Tositumomab 450 mg
Drug: Tositumomab 35 mg
Enrollment:
93
Observational study model:
Not applicable
Primary completion date:
2007-28-02
Time perspective:
Not applicable
Clinical publications:
Harold J. Olney, Marni A. Freeman, Douglas A. Stewart, Joy E. Mangel, Darrell J. White, Guylaine Gaudet, Julia O. Elia-Pacitti.Prolonged Progression-Free Survival and Preserved Quality of Life in the Canadian Prospective Study of Tositumomab and Iodine131-Tositumomab (TST/I131-TST) for Relapsed/Refractory, Rituximab-exposed, Indolent non-Hodgkin Lymphoma.2014;55(12):2754-60
Medical condition
Lymphoma, Non-Hodgkin
Product
tositumomab
Collaborators
Not applicable
Study date(s)
April 2004 to September 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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).
- Received chemotherapy, radiation therapy, immunosuppressants or cytokine treatment within 4 weeks prior to study entry.
- Have active obstructive hydronephrosis.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-28-02
Actual study completion date
2011-07-09
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.
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