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Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00088881
First received: August 4, 2004
Last updated: February 17, 2015
Last verified: February 2015
Results First Received: December 16, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Splenic Marginal Zone Lymphoma
Stage I Adult Diffuse Large Cell Lymphoma
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions: Biological: rituximab
Drug: prednisone
Drug: cyclophosphamide
Drug: doxorubicin
Drug: vincristine
Radiation: indium In 111 ibritumomab tiuxetan
Radiation: radiation therapy
Procedure: positron emission tomography

  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
No text entered.

Reporting Groups
  Description
Treatment

R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.

Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.

Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.


Participant Flow for 3 periods

Period 1:   Step 1 - R-CHOP
    Treatment  
STARTED     62  
Eligible and Treated     53  
COMPLETED     48  
NOT COMPLETED     14  
Patient ineligible                 9  
Adverse Event                 1  
Withdrawal by Subject                 2  
Physician Decision                 1  
Insurance company refused to cover                 1  

Period 2:   Step 2 - Zevalin™ Radioimmunotherapy
    Treatment  
STARTED     56 [1]
Eligible and Treated     48  
COMPLETED     45  
NOT COMPLETED     11  
Patient ineligible                 8  
Unknown                 3  
[1] This includes all patients who received step 2 treatment regardless of eligibility.

Period 3:   Step 3 - Radiation Therapy
    Treatment  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     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.
Eligible and treated patients

Reporting Groups
  Description
Treatment

R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.

Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.

Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.


Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  53  
Age  
[units: years]
Median (Full Range)
  62  
  (20 to 84)  
Gender  
[units: participants]
 
Female     21  
Male     32  



  Outcome Measures
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1.  Primary:   Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.   [ Time Frame: Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin ]

2.  Primary:   Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.   [ Time Frame: Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin ]

3.  Secondary:   3-year Time to Treatment Failure (TTF) Rate   [ Time Frame: Assessed every 3 months for one year; every 4 months for the second year; then every 6 months for 3 years; then annually to 10 years from patient entry. ]

4.  Secondary:   3-year Overall Survival (OS) Rate   [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years; then annually to 10 years from patient entry. ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI 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



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00088881     History of Changes
Other Study ID Numbers: NCI-2012-02957
E3402 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
U10CA021115 ( US NIH Grant/Contract Award Number )
Study First Received: August 4, 2004
Results First Received: December 16, 2014
Last Updated: February 17, 2015
Health Authority: United States: Food and Drug Administration