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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00156013
First Posted: September 12, 2005
Last Update Posted: November 29, 2017
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.
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
Results First Submitted: October 6, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
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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
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.
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Reporting Groups
  Description
Clofarabine Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.

Baseline Measures
   Clofarabine 
Overall Participants Analyzed 
[Units: Participants]
 33 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      13  39.4% 
>=65 years      20  60.6% 
Age 
[Units: Years]
Mean (Full Range)
 69 
 (27 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      19  57.6% 
Male      14  42.4% 
Region of Enrollment 
[Units: Participants]
 
United States   33 


  Outcome Measures
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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 ]

3.  Secondary:   Toxicity   [ Time Frame: 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:  
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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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)
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: October 6, 2011
Results First Posted: July 9, 2012
Last Update Posted: November 29, 2017