Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma

This study has been terminated.
(Slow accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00070291
First received: October 3, 2003
Last updated: February 12, 2013
Last verified: February 2013
Results First Received: January 7, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Intervention: Drug: cyclosporine

  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
Participants were recruited from ECOG member institutions between September 2, 2005 and March 24, 2009. The study was terminated due to slow accrual.

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
Cyclosporine

Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.

High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment.


Participant Flow for 2 periods

Period 1:   Step 1
    Cyclosporine  
STARTED     4  
Treated     3  
COMPLETED     2  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Adverse Event                 1  

Period 2:   Step 2
    Cyclosporine  
STARTED     1 [1]
COMPLETED     0  
NOT COMPLETED     1  
Adverse Event                 1  
[1] One patient completed step 1, but opted to get alternative therapy. One patient entered step 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
Cyclosporine No text entered.

Baseline Measures
    Cyclosporine  
Number of Participants  
[units: participants]
  4  
Age  
[units: years]
Median ( Full Range )
  62  
  ( 42 to 65 )  
Gender  
[units: participants]
 
Female     1  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Rate (Complete and Partial Response)   [ Time Frame: Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up. ]

2.  Secondary:   Overall Survival   [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 1 year. ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


No publications provided


Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00070291     History of Changes
Other Study ID Numbers: CDR0000331864, U10CA021115, E2402
Study First Received: October 3, 2003
Results First Received: January 7, 2013
Last Updated: February 12, 2013
Health Authority: United States: Federal Government