Study of Iodine-131 Anti-B1 Antibody for Patients With Non Hodgkin's Lymphoma Who Have Previously Received Rituximab

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
Participants received radioimmunotherapy of tositumomab (TST) and Iodine I 131 TST in 2 phases: Phase 1, dosimetric dose; Phase 2, therapeutic dose. After radioimmunotherapy, participants could have entered a 10-year Long-Term Follow-Up study (Study BEX104526; NCT00240591) for continued evaluation.

Reporting Groups

Description

TST and Iodine I 131 TST

Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Participant Flow for 2 periods

Period 1:   Dosimetric and Therapeutic Treatment

	TST and Iodine I 131 TST
STARTED	43
COMPLETED	0
NOT COMPLETED	43
Lost to Follow-up	7
Withdrawal by Subject	3
Progressive Disease	22
Death	1
Enrolled in BEX104526	6
Did Not Receive Any Study Drug	3
Non-compliance	1

Period 2:   Long-Term Follow-Up

	TST and Iodine I 131 TST
STARTED	9 [1]
COMPLETED	6
NOT COMPLETED	3
Withdrawal by Subject	2
Site Closed	1

Reporting Groups

Description

TST and Iodine I 131 TST

Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Baseline Measures

	TST and Iodine I 131 TST
Number of Participants   [units: participants]	40
Age [1] [units: Years] Mean ± Standard Deviation	57.0  ± 11.8
Gender [1] [units: Participants]
Female	13
Male	27
Race/Ethnicity, Customized [1] [units: participants]
White	33
Hispanic	3
Asian	1
Black	3

1.  Primary:

Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

2.  Primary:

Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

3.  Primary:

Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

4.  Primary:

Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

5.  Primary:

Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

6.  Primary:

Duration of Response for Confirmed CR as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

7.  Primary:

Duration of Response for CR and CCR as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

8.  Primary:

Duration of Response for All Confirmed Partial Responders as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

9.  Primary:

Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Responders in This Study   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

10.  Primary:

Duration of Response for All Participants Classified as Responders With or Without a Prior Response to Rituximab   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

11.  Primary:

Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Having a Complete Response (CR) in This Study   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

12.  Primary:

Duration of Response for All Participants With CR With or Without a Prior Response to Rituximab   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

13.  Primary:

Progression-free Survival for Participants With or Without a Prior Response to Rituximab   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

14.  Primary:

Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

15.  Primary:

Overall Survival   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

16.  Secondary:

Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

17.  Secondary:

Number of Participants With the Indicated Type of Infection   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

18.  Secondary:

Number of Participants With an Infection for Which Anti-infectives Were Administered   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

19.  Secondary:

Number of Participants With Serious Adverse Events (SAE) Related to Study Drug   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

20.  Secondary:

Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

21.  Secondary:

Nadir Values for ANC, a Hematologic Parameter   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

22.  Secondary:

Nadir Values for Hemoglobin, a Hematologic Parameter   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

23.  Secondary:

Nadir Values for Hematologic Parameters Platelets and WBC Count   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

24.  Secondary:

Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

25.  Secondary:

Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]