Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00581854
First received: December 19, 2007
Last updated: June 25, 2014
Last verified: June 2014
Results First Received: December 2, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Mantle Cell Lymphoma
Intervention: Drug: modified Hyper-CVAD

  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
Rituximab Single Arm Maintenance rituximab following induction chemoimmunotherapy

Participant Flow:   Overall Study
    Rituximab  
STARTED     22  
COMPLETED     22  
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.
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Reporting Groups
  Description
Group 1 SAEs during induction therapy

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
  22  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     9  
Gender  
[units: participants]
 
Female     2  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     22  



  Outcome Measures

1.  Primary:   Complete Response Rate to Induction Therapy   [ Time Frame: Median follow up of 37 months ]


  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: Brad S Kahl, MD
Organization: University of Wisconsin
phone: 608-263-1836
e-mail: bsk@medicine.wisc.edu


Publications:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00581854     History of Changes
Other Study ID Numbers: HO00401
Study First Received: December 19, 2007
Results First Received: December 2, 2011
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board