Comparison Of Rituximab Versus Tositumomab and Iodine I 131 Tositumomab (BEXXAR® Therapeutic Regimen) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma

This study has been terminated.

(Study was stopped early due to lack of feasibility. Subjects originally treated in SB393220/028 continue long-term follow-up evaluations in Study BEX104528.)

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00268983

First received: December 21, 2005

Last updated: December 9, 2010

Last verified: December 2010

History of Changes

Results First Received: June 29, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Lymphoma, Non-Hodgkin Non-Hodgkin's Lymphoma
Interventions:	Biological: Tositumomab and Iodine I 131 Tositumomab Biological: Rituximab

Participant Flow

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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

Baseline Characteristics

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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
Total	Total of all reporting groups

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

Outcome Measures

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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) ]

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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 ]

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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 ]

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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 ]

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Measure Type	Secondary
Measure Title	Number of Participants With the Indicated Duration of Response
Measure Description	The median duration of response could not be presented for participants in either treatment group; thus, data are shown as the 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Exposed Population. Duration of response could be calculated for 2 participants in the Rituximab group and 3 participants in the Bexxar group. Other participants who had a response were censored in the analysis.

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

Measured Values

	Rituximab 375 mg/m^2	Bexxar
Number of Participants Analyzed [units: participants]	2	3
Number of Participants With the Indicated Duration of Response [units: participants]
4 months	0	1
6.0 months	1	0
7.3 months	1	0
19 months	0	1
28 months	0	1

No statistical analysis provided for Number of Participants With the Indicated Duration of Response

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) ]

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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) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00268983 History of Changes
Other Study ID Numbers:	393229/028, CCBX001-049
Study First Received:	December 21, 2005
Results First Received:	June 29, 2010
Last Updated:	December 9, 2010
Health Authority:	United States: Food and Drug Administration

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