Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies

Phase 2

Completed

Conditions: Lymphoma, Non-Hodgkin

Interventions: Biological: Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab

Registration Number: NCT01224821

Lead Sponsor: GlaxoSmithKline

Brief Summary: Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). The primary objective of this study is to demonstrate that each site could accurately conduct the whole body dosimetry required for the safe and effective dosing of Iodine-131 Anti-B1 Antibody. Additional objectives of this study are to evaluate the efficacy, dosimetry, and safety of Iodine-131 Anti-B1 Antibody.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tositumomab and Iodine I-131 Tositumomab	Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab	Patients receive a dosimetric dose consisting of 450 milligrams (mg) of unlabeled tositumomab (TST, Anti-B1 Antibody) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after administration and then daily for the next 7 days were used to determine the radioactive clearance and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose. The therapeutic dose was administered 7-14 days after the dosimetric dose and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites	Day 1 within one hour of infusion (I) and prior to urination (U); Days 2, 3, and 4 after dosimetric dose (DD) I, following U; Days 6 and 7 after DD I, following U	The dosimetry methods were validated for seven different clinical research sites.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose)	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Based on their platelet count and body weight. Participants received different TDs of TST. For obese participants (weighing more than 137% of their calculated lean body weight), the calculation to determine the administered activity (mCi) was performed using the maximum effective mass (i.e., the minimum of the participant's mass and 137% of their calculated lean body weight). The administered activity (mCi) for participants with a Baseline platelet count of 100001-149999 cells/millimeter cubed (mm\^3) was reduced to a 65 cGy total body dose, after any adjustment for obesity.
Number of Participants With Confirmed Response (CR, CCR, or PR), as Assessed by the Investigator	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).
Number of Participants (Par.) With Response (CR, CCR, or PR), as Assessed by the Investigator	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).
Duration of Response for All Confirmed Responders (CR, CCR, or PR), as Assessed by the Investigator	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Duration of Response for All Confirmed Complete Responders, as Assessed by the Investigator	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Duration of Response for All Unconfirmed Complete Responders, as Assessed by the Investigator	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Number of Participants With Confirmed CR and CCR, as Assessed by the Investigator	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	The total number of participants with CR and CCR was reported. Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.
Duration of Response for All Unconfirmed Responders (CR, CCR, or PR), as Assessed by the Investigator	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Duration of Response for All Confirmed Clinical Complete Responders, as Assessed by the Investigator	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Time to Disease Progression or Death for Responders, as Assessed by the Investigator	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.
Time to Disease Progression or Death for All Participants, as Assessed by the Investigator	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.
Number of Participants With CR and CCR, as Assessed by the Investigator	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	The total number of participants with CR and CCR was reported. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.
Duration of Response for All Unconfirmed Clinical Complete Responders, as Assessed by the Investigator	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Median Time to Treatment Failure for All Participants	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.
Overall Survival	Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months	Overall survival is defined as the time from the treatment start date to the date of death from any cause. Time to death is the time from the dosimetric dose to the date of death.