Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma

GlaxoSmithKline93 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma, Non-Hodgkin

Interventions

Tositumomab 450 mgDRUG

Unlabeled TST

Tositumomab 35 mgDRUG

TST labeled with 185 megaBecqueral (mbq) of iodine 131

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (11)

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Halifax, Nova Scotia, Canada

Outcomes

Primary Outcomes

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.

Time frame: Week 26

Secondary Outcomes

Complete response rate (CR)

Investigator-assessed confirmed CR is defined as the disappearance of all clinical and radiological evidence of lymphoma. Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation.

Time frame: 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

Duration of response is defined as the time from the first documented response to the first documented disease progression. Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation. Disease progression is defined as a 50% increase in the sum of the products of the two perpendicular diameters of all measurable lesions, or the appearance of new lesions.

Time frame: 5 years

Progression-free survival (PFS)

PFS is defined as the time interval between the date of the DD to the first date at which progressive disease (PD) or death is observed. PD is defined as a 50% increase in the sum of the products of two perpendicular diameters of all measurable lesions, or the appearance of new lesions. Participants with no evidence of PD were censored to the last date of contact; and those who died for any reason in the absense of PD were classified as having experienced PD on the date of death. For non-responders, duration of PFS was recorded as 0. Participants were censored if they withdrew without PD.

Data from ClinicalTrials.gov

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