Clofarabine for Relapsed or Refractory T-Cell or B-Cell Non-Hodgkin Lymphoma (NHL)

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier:
NCT00156013
First received: September 8, 2005
Last updated: June 19, 2014
Last verified: June 2014
Results First Received: October 6, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Intervention: Drug: CLOFARABINE

  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
Clofarabine Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.

Participant Flow:   Overall Study
    Clofarabine  
STARTED     33  
COMPLETED     31  
NOT COMPLETED     2  



  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
Clofarabine Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.

Baseline Measures
    Clofarabine  
Number of Participants  
[units: participants]
  33  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     33  
Age  
[units: years]
Mean ( Full Range )
  69  
  ( 27 to 85 )  
Gender  
[units: participants]
 
Female     19  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     33  



  Outcome Measures

1.  Primary:   Phase I Maximum Tolerated Dose   [ Time Frame: days 1 -28, maximum 6 cycles ]

2.  Primary:   Phase II Overall Response   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Time to Treatment Failure   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Toxicity   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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: Chadi Nabhan, MD
Organization: Oncology Specialists
phone: 847-268-8200
e-mail: cnabhan@oncmed.net


No publications provided by Oncology Specialists, S.C.

Publications automatically indexed to this study:

Responsible Party: Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT00156013     History of Changes
Obsolete Identifiers: NCT00305721
Other Study ID Numbers: 1066306 (0408)
Study First Received: September 8, 2005
Results First Received: October 6, 2011
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board