Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00058019
First received: April 7, 2003
Last updated: May 7, 2014
Last verified: October 2011
Results First Received: August 19, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anaplastic Large Cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Intervention: Drug: ixabepilone

  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
One patient never received treatment and was excluded from analysis.

Reporting Groups
  Description
Cohort 1 (Chemosensitive) Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
Cohort 2 (Chmoresistant) Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.

Participant Flow:   Overall Study
    Cohort 1 (Chemosensitive)     Cohort 2 (Chmoresistant)  
STARTED     39     12  
COMPLETED     39     12  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Cohort 1 (Chemosensitive) Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
Cohort 2 (Chmoresistant) Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
Total Total of all reporting groups

Baseline Measures
    Cohort 1 (Chemosensitive)     Cohort 2 (Chmoresistant)     Total  
Number of Participants  
[units: participants]
  39     12     51  
Age  
[units: years]
Median ( Full Range )
  64  
  ( 44 to 90 )  
  73  
  ( 53 to 87 )  
  66  
  ( 44 to 90 )  
Gender  
[units: participants]
     
Female     12     5     17  
Male     27     7     34  
Race/Ethnicity, Customized  
[units: Participants]
     
Caucasian     34     12     46  
African American     1     0     1  
Hispanic     4     0     4  
LDH elevation  
[units: Participants]
     
Yes     16     6     22  
No     23     6     29  
Prior therapies  
[units: Participants]
     
1     10     4     14  
2-3     17     5     22  
4 or more     12     3     15  
Prior rituximab  
[units: Participants]
     
Yes     34     11     45  
No     5     1     6  



  Outcome Measures
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1.  Primary:   Objective Overall Response Rate   [ Time Frame: up to 3 years ]

2.  Primary:   Safety and Toxicity of Ixabepilone   [ Time Frame: up to 3 years ]

3.  Secondary:   Duration of Response   [ Time Frame: up to 3 years ]

4.  Secondary:   Overall Survival   [ Time Frame: up to 3 years ]

5.  Secondary:   Time to Progression   [ Time Frame: up to 3 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
No text entered.


  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: Dr. Sonali M. Smith
Organization: University of Chicago Medical Center
phone: 773-834-2895
e-mail: smsmith@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00058019     History of Changes
Obsolete Identifiers: NCT01660269
Other Study ID Numbers: NCI-2009-00031, NCI-2009-00031, NCI-5913, UCCRC-NCI-5913, CDR0000285683, UCCRC-11965B, 11965B, 5913, P30CA014599, N01CM62202, N01CM62201
Study First Received: April 7, 2003
Results First Received: August 19, 2013
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration