Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study intended to recruit 506 participants to be randomized (1:1) to one of two treatment arms. However, due to feasibility issues, the study was stopped after only 15 participants were enrolled. Of these, 1 participant withdrew prior to receiving the first dose of study treatment; therefore, only 14 comprised the study population.

Reporting Groups

	Description
Rituximab 375 mg/m^2	Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
Bexxar	Dosimetric dose, given once on Day 1: Tositumomab infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab infused over 20 minutes; Therapeutic dose, given only once between Day 7 and Day 14: 450 mg Tositumomab infused over 1 hour, followed by individualized mCi activity of I 131 Tositumomab (35 mg) infused over 20 minutes

Participant Flow:   Overall Study

	Rituximab 375 mg/m^2	Bexxar
STARTED	6	8
COMPLETED	0	0
NOT COMPLETED	6	8
Death	3	0
Study Stopped	3	8

Reporting Groups

	Description
Rituximab 375 mg/m^2	Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
Bexxar	Dosimetric dose, given once on Day 1: Tositumomab infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab infused over 20 minutes; Therapeutic dose, given only once between Day 7 and Day 14: 450 mg Tositumomab infused over 1 hour, followed by individualized mCi activity of I 131 Tositumomab (35 mg) infused over 20 minutes

Baseline Measures

	Rituximab 375 mg/m^2	Bexxar	Total
Number of Participants   [units: participants]	6	8	14
Age   [units: years] Mean ± Standard Deviation	58.2  ± 14.4	53.1  ± 8.0	53.3  ± 11.0
Gender   [units: participants]
Female	3	4	7
Male	3	4	7
Race/Ethnicity, Customized   [units: participants]	6	8	14

1.  Primary:

Progression-free Survival   [ Time Frame: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and Bexxar groups was 38.9 and 42.2 months, respectively) ]

2.  Secondary:

Number of Participants Achieving Response   [ Time Frame: Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually ]

3.  Secondary:

Duration of Response   [ Time Frame: Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually ]

4.  Secondary:

Number of Participants With the Indicated Duration of Response   [ Time Frame: Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually ]

5.  Secondary:

Time to Death   [ Time Frame: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and Bexxar groups was 38.9 and 42.2 months, respectively) ]

6.  Secondary:

Number of Participants Who Had Died by the Month Indicated   [ Time Frame: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and Bexxar groups was 38.9 and 42.2 months, respectively) ]