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Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00075946
First received: January 12, 2004
Last updated: June 3, 2015
Last verified: June 2015
Results First Received: February 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Intervention: 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
The study was opened on Nov 21, 2003, and closed on Sept 12, 2008, with final accrual of 545 patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients received induction rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms, stratified on histology (follicular vs other), age, and time from diagnosis.

Reporting Groups
  Description
Rituximab Retreatment: Follicular Patients Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
Rituximab Scheduled: Follicular Patients Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
Rituximab Retreatment: Non-Follicular Patients Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
Rituximab Scheduled: Non-Follicular Patients Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
Enrolled But Not Randomized Patients who were enrolled in the study but not proceed to randomization. These could include patients with undetermined histology as well as those who did not achieve response (PR or CR) after induction rituximab.

Participant Flow:   Overall Study
    Rituximab Retreatment: Follicular Patients   Rituximab Scheduled: Follicular Patients   Rituximab Retreatment: Non-Follicular Patients   Rituximab Scheduled: Non-Follicular Patients   Enrolled But Not Randomized
STARTED   148   151   28   30   188 
Treated and With Toxicity Data Available   142   148   27   29   154 
Included in Primary Analysis   143   146   23   29   0 
COMPLETED   0   0   0   0   0 
NOT COMPLETED   148   151   28   30   188 
Path ineligible: undetermined histology                0                0                0                0                6 
Did not achieve response after induction                0                0                0                0                182 
Incorrectly randomized (no response)                5                5                5                1                0 
Still on treatment at time of analysis                52                19                3                9                0 
Adverse Event                2                10                0                2                0 
Death                0                1                0                0                0 
Withdrawal by Subject                23                58                4                9                0 
Alternative therapy                16                2                5                0                0 
Other complicating disease                7                13                1                4                0 
No response to retreatment                23                0                2                0                0 
Time to progression less than 6 months                15                30                8                3                0 
Other                5                13                0                2                0 



  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.
As the primary analysis only includes randomized patients, the baseline characteristics were provided among patients who were correctly randomized to one of the two arms for maintenance therapy.

Reporting Groups
  Description
Rituximab Retreatment: Follicular Patients Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
Rituximab Scheduled: Follicular Patients Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
Rituximab Retreatment: Non-Follicular Patients Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
Rituximab Scheduled: Non-Follicular Patients Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
Total Total of all reporting groups

Baseline Measures
   Rituximab Retreatment: Follicular Patients   Rituximab Scheduled: Follicular Patients   Rituximab Retreatment: Non-Follicular Patients   Rituximab Scheduled: Non-Follicular Patients   Total 
Overall Participants Analyzed 
[Units: Participants]
 143   146   23   29   341 
Age 
[Units: Years]
Median (Full Range)
 59 
 (25 to 86) 
 58 
 (25 to 86) 
 61 
 (47 to 86) 
 65 
 (38 to 85) 
 60 
 (25 to 86) 
Gender 
[Units: Participants]
         
Female   76   80   16   14   186 
Male   67   66   7   15   155 


  Outcome Measures
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1.  Primary:   Time to Rituximab Failure (TTRF)   [ Time Frame: Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first. ]

2.  Secondary:   Time to First Cytotoxic Therapy (TTFC)   [ Time Frame: Assessed every 13 weeks until rituximab failure observed or August 2013, whichever occurred first. ]

3.  Secondary:   Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization   [ Time Frame: Assessed at baseline and 6 months after randomization. ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


Publications of Results:

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00075946     History of Changes
Other Study ID Numbers: CDR0000346359
U10CA021115 ( US NIH Grant/Contract Award Number )
ECOG-E4402 ( Other Identifier: Eastern Cooperative Oncology Group )
Study First Received: January 12, 2004
Results First Received: February 9, 2015
Last Updated: June 3, 2015
Health Authority: United States: Federal Government