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MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00430352
First received: January 31, 2007
Last updated: June 3, 2015
Last verified: June 2015
Results First Received: September 4, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Hodgkin's Lymphoma
Intervention: Drug: rituximab [MabThera/Rituxan]

  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
No text entered.

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
Rituximab 375 Milligrams Per Square Meter (mg/m^2) Participants received rituximab 375 mg/m^2 intravenously (IV) once every 8 weeks for a total 12 infusions until progression, relapse, start of a new treatment, death, or toxicity.

Participant Flow:   Overall Study
    Rituximab 375 Milligrams Per Square Meter (mg/m^2)  
STARTED     545  
COMPLETED     407  
NOT COMPLETED     138  
Disease progression                 58  
Withdrawal by Subject                 11  
Adverse Event                 16  
Death                 5  
Not specified                 48  



  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.
Intent-to-treat (ITT) population: all participants who completed a baseline visit and at least 1 further assessment.

Reporting Groups
  Description
Rituximab 375 mg/m^2 Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.

Baseline Measures
    Rituximab 375 mg/m^2  
Number of Participants  
[units: participants]
  545  
Age  
[units: years]
Mean (Standard Deviation)
  56.3  (11.47)  
Gender  
[units: participants]
 
Female     313  
Male     232  



  Outcome Measures
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1.  Primary:   Percentage of Participants With an Adverse Event (AE) - Overall Summary   [ Time Frame: 24 months ]

2.  Secondary:   Progression-Free Survival - Percentage of Participants With an Event   [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ]

3.  Secondary:   Progression-Free Survival - Time to Event   [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ]

4.  Secondary:   Event-Free Survival (EFS) - Percentage of Participants With an Event   [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ]

5.  Secondary:   Event-Free Survival (EFS) - Time to Event   [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ]

6.  Secondary:   Overall Survival (OS) - Percentage of Participants With an Event   [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ]

7.  Secondary:   Overall Survival (OS) - Time to Event   [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ]

8.  Secondary:   Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event   [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ]

9.  Secondary:   Time to NLT - Time to Event   [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ]

10.  Secondary:   Percentage of Participants With Response by Best Response to Study Treatment   [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ]

11.  Secondary:   Percentage of Participants With PR Who Converted to CRu   [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00430352     History of Changes
Other Study ID Numbers: MO19872
Study First Received: January 31, 2007
Results First Received: September 4, 2014
Last Updated: June 3, 2015
Health Authority: Italy: Ministry of Health