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Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00460109
First received: April 11, 2007
Last updated: March 7, 2017
Last verified: March 2017
Results First Received: January 18, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Biological: denileukin diftitox
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
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
Rituximab + Denileukin Diftitox Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Rituximab + Denileukin Diftitox
STARTED   24 
COMPLETED   23 
NOT COMPLETED   1 
Death                1 



  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
Rituximab + Denileukin Diftitox Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Rituximab + Denileukin Diftitox 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Years]
Median (Full Range)
 60.0 
 (27.0 to 79.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  47.8% 
Male      12  52.2% 
Region of Enrollment 
[Units: Participants]
 
United States   23 


  Outcome Measures
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1.  Primary:   Proportion of Confirmed Tumor Response (Complete Response [CR], Unconfirmed CR, and Partial Response)   [ Time Frame: Up to 5 years ]

2.  Secondary:   Survival Time   [ Time Frame: Up to 5 years ]

3.  Secondary:   Time to Disease Progression   [ Time Frame: Up to 5 years ]

4.  Secondary:   Duration of Response   [ Time Frame: Up to 5 years ]

5.  Secondary:   Time to Subsequent Therapy   [ Time Frame: Up to 5 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stephen M. Ansell, M.D., Ph.D.
Organization: Mayo Clinic
phone: 507/284-4642
e-mail: ansell.stephen@mayo.edu


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00460109     History of Changes
Other Study ID Numbers: NCCTG-N0682
NCI-2009-00662 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000539551 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: April 11, 2007
Results First Received: January 18, 2017
Last Updated: March 7, 2017