Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody Plus CHOP For Untreated Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00992992
First received: October 8, 2009
Last updated: February 27, 2014
Last verified: November 2013
Results First Received: February 27, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma, Mantle-Cell
Intervention: Biological: Tositumomab and Iodine I 131 Tositumomab followed by CHOP

  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
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Reporting Groups
  Description
Iodine I-131 Tositumomab + CHOP Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).

Participant Flow:   Overall Study
    Iodine I-131 Tositumomab + CHOP  
STARTED     25  
COMPLETED     0  
NOT COMPLETED     25  
Lost to Follow-up                 3  
Death                 16  
GlaxoSmithKline Closed the Study                 2  
Sponsor Closed the Study                 4  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Iodine I-131 Tositumomab + CHOP Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).

Baseline Measures
    Iodine I-131 Tositumomab + CHOP  
Number of Participants  
[units: participants]
  25  
Age  
[units: Years]
Mean ± Standard Deviation
  64.4  ± 9.6  
Gender  
[units: Participants]
 
Female     2  
Male     23  
Race/Ethnicity, Customized  
[units: participants]
 
White     24  
Hispanic     1  



  Outcome Measures
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1.  Primary:   Number of Participants With the Indicated Unconfirmed Response (Complete Response, Complete Response Unconfirmed, and Partial Response)   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

2.  Secondary:   Number of Participants With the Indicated Confirmed Response (Confirmed Complete Response, Complete Response Unconfirmed, and Partial Response)   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

3.  Secondary:   Duration of Response for All Confirmed Responders (CR + CRu + PR)   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

4.  Secondary:   Duration of Response for All Unconfirmed Responders (CR + CRu + PR)   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

5.  Secondary:   Duration of Response for Unconfirmed Complete Responders   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

6.  Secondary:   Duration of Response for Confirmed Complete Responders   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

7.  Secondary:   Progression-free Survival   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

8.  Secondary:   Time to Treatment Failure   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

9.  Secondary:   Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

10.  Secondary:   Mean Nadir Value for Absolute Neutrophil Count (ANC)   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

11.  Secondary:   Mean Nadir Value for Hemoglobin   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

12.  Secondary:   Mean Nadir Values for Platelets and White Blood Cell (WBC) Count   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

13.  Secondary:   Time to Nadir for the Indicated Hematology Parameters   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

14.  Secondary:   Time to Recovery From the Indicated Hematology Parameters   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

15.  Secondary:   Number of Participants Negative for Human Anti-Murine (Mouse) Antibody (HAMA) at Screening Who Converted to HAMA Positivity or Remained Negative During the Course of the Study   [ Time Frame: Screening; at Week 7, Week 13, then every 6 months until disease progression or death (up to 143 months) ]

16.  Secondary:   Number of Participants With an Adverse Event of Cytopenia   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]

17.  Secondary:   Overall Survival   [ Time Frame: Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months) ]


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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.


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
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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00992992     History of Changes
Other Study ID Numbers: 393229/005
Study First Received: October 8, 2009
Results First Received: February 27, 2014
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration