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Trial record 31 of 390 for:    Lymphoma AND (women OR woman OR female)

Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00684411
Recruitment Status : Completed
First Posted : May 26, 2008
Results First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Collaborators:
Brigham and Women's Hospital
Novartis
Information provided by (Responsible Party):
Eric Jacobsen, MD, Dana-Farber Cancer Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: T Cell Non-Hodgkin Lymphoma
Intervention: Drug: Imatinib mesylate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
12 participants were enrolled between August 2008 and December 2011.

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
Imatinib Mesylate The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.

Participant Flow:   Overall Study
    Imatinib Mesylate
STARTED   12 
Disease Evaluable   11 
COMPLETED   0 
NOT COMPLETED   12 
New Primary Cancer                1 
Disease Progression                10 
Adverse Event                1 



  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.
No text entered.

Reporting Groups
  Description
Imatinib Mesylate The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.

Baseline Measures
   Imatinib Mesylate 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Median (Full Range)
 70.7 
 (40 to 82) 
Gender 
[Units: Participants]
Count of Participants
 
Female      6  50.0% 
Male      6  50.0% 
Region of Enrollment 
[Units: Participants]
 
United States   12 
International Prognostic Index (IPI) [1] 
[Units: Participants]
 
Low   3 
Low-Intermediate   5 
High-Intermediate   3 
High   1 
[1] Low risk: 0 – 1 points, low-intermediate risk: 2 points, high-intermediate risk: 3 points, high risk: 4 – 5 points based on risk factors of >60 years of age; stage III or IV disease; elevated serum LDH; ECOG performance status 2, 3 or 4; and >1 extranodal site.


  Outcome Measures

1.  Primary:   Overall Response Rate   [ Time Frame: Disease was evaluated radiologically at baseline, weeks 8, 16, 24 and every 12 weeks thereafter on treatment. Treatment duration was a median of 56 days (range 5-253 days). ]

2.  Secondary:   Progression-Free Survival   [ Time Frame: Disease was evaluated radiologically at baseline, on treatment at weeks 8, 16, 24 and every 12 weeks thereafter, off treatment for 6 weeks or until death, whichever occurs first. Treatment duration was a median of 56 days (range 5-253 days). ]

3.  Secondary:   Overall Survival   [ Time Frame: Participants were followed long-term for survival for the earlier of 6 weeks from the end of treatment or death. Maximum follow-up was 288 days in this study cohort. ]


  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
No text entered.


  More Information

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: Eric Jacobsen, MD
Organization: Dana-Farber Cancer Institute
phone: 617.632.6633
e-mail: EDJACOBSEN@PARTNERS.ORG


Publications of Results:

Responsible Party: Eric Jacobsen, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00684411     History of Changes
Other Study ID Numbers: 08-063
First Submitted: May 22, 2008
First Posted: May 26, 2008
Results First Submitted: September 11, 2016
Results First Posted: January 5, 2017
Last Update Posted: January 5, 2017