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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00581854
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Mantle Cell Lymphoma
Intervention: Drug: modified Hyper-CVAD

  Participant Flow

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
Rituximab Single Arm Maintenance rituximab following induction chemoimmunotherapy

Participant Flow:   Overall Study

  Baseline Characteristics

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
Group 1 SAEs during induction therapy

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   13 
>=65 years   9 
[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

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

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


Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00581854     History of Changes
Other Study ID Numbers: HO00401
First Submitted: December 19, 2007
First Posted: December 28, 2007
Results First Submitted: December 2, 2011
Results First Posted: July 21, 2014
Last Update Posted: July 21, 2014