Clinical trial NCT00240565: Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Keywords: BEXXAR
non-Hodgkin's Lymphoma
tositumomab
I-131
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Response Rate
timeFrame: Week 26
Secondary outcomes:
measure: Complete response rate (CR)
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)
measure: Duration of response
timeFrame: 5 years
measure: Progression-free survival (PFS)
timeFrame: 5 years or until death
measure: Adverse events
timeFrame: 5 years or until death
measure: Quality of Life
timeFrame: 5 Years
measure: Resource Utilization Assessment
timeFrame: Week 26
measure: Duration of Overall Survival
timeFrame: 5 years or until death
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Quebec
country: Canada
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.