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Trial record 31 of 395 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
Enrollment 12

Recruitment Details 12 participants were enrolled between August 2008 and December 2011.
Pre-assignment Details  
Arm/Group Title Imatinib Mesylate
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 12
Disease Evaluable 11
Completed 0
Not Completed 12
Reason Not Completed
New Primary Cancer             1
Disease Progression             10
Adverse Event             1
Arm/Group Title Imatinib Mesylate
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
70.7
(40 to 82)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
6
  50.0%
Male
6
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
International Prognostic Index (IPI)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
Low 3
Low-Intermediate 5
High-Intermediate 3
High 1
[1]
Measure Description: 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.
1.Primary Outcome
Title Overall Response Rate
Hide Description

Overall response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on International Workshop Criteria (IWC) [Cheson, et al. JCO 2007].

Per the International Working Group response criteria in lymphoma (Cheson 2007) for target lesions assessed by CT: Complete response (CR): nodes that were greater than 15 mm in greatest transverse diameter at baseline shrank to less than 15 mm in greatest transverse diameter and those that were 11-15 mm in greatest transverse diameter but had a short axis diameter greater than 10 mm had a short axis diameter less than 10mm and a transverse diameter that remained less than 15 mm; partial response (PR) was defined as a decrease in the sum of the product of the diameter of target lesions by more than 50% but not fulfilling criteria for CR. Overall response was defined as CR+PR.

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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.
Arm/Group Title Imatinib Mesylate
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion of participants
0.0
(0.0 to 0.238)
2.Secondary Outcome
Title Progression-Free Survival
Hide Description

Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Disease progression was assessed per International Workshop Criteria (IWC) [Cheson, et al. JCO 2007].

Per International Working Group response criteria in lymphoma progressive disease (PD) was defined as the appearance of new lesions; the sum of the product of the diameter (SPD) increasing ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall; or, in any single nodal target lesion, a node with a short axis > 10 mm must increase > 50% in greatest transverse diameter or a node with short axis <10mm must increase by at least 50% to at least 15 mm x 15 mm or have a greatest transverse diameter greater than 15 mm.

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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.
Arm/Group Title Imatinib Mesylate
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Median (90% Confidence Interval)
Unit of Measure: days
21
(15 to 28)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from study entry to death or date last known alive.
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.
Arm/Group Title Imatinib Mesylate
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Median (90% Confidence Interval)
Unit of Measure: days
154
(35 to 242)
Time Frame Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36.
Adverse Event Reporting Description Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
 
Arm/Group Title Imatinib Mesylate
Hide Arm/Group Description 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.
All-Cause Mortality
Imatinib Mesylate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Imatinib Mesylate
Affected / at Risk (%)
Total   5/12 (41.67%) 
Blood and lymphatic system disorders   
Hemoglobin  1  2/12 (16.67%) 
Investigations   
Leukocytes  1  1/12 (8.33%) 
Lymphophenia  1  4/12 (33.33%) 
Neutrophils  1  1/12 (8.33%) 
Metabolism and nutrition disorders   
Hypophosphatemia  1  1/12 (8.33%) 
Hypokalemia  1  1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
Rash/Desquamation  1  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEv3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Imatinib Mesylate
Affected / at Risk (%)
Total   10/12 (83.33%) 
Blood and lymphatic system disorders   
Hemoglobin  1  3/12 (25.00%) 
Cardiac disorders   
Cardiac  1  1/12 (8.33%) 
Eye disorders   
Vision-blurred  1  1/12 (8.33%) 
Vision-flashing lights/floaters  1  1/12 (8.33%) 
Ocular  1  1/12 (8.33%) 
Gastrointestinal disorders   
Diarrhea w/o prior colostomy  1  2/12 (16.67%) 
Dyspepsia  1  1/12 (8.33%) 
Nausea  1  4/12 (33.33%) 
Vomiting  1  2/12 (16.67%) 
General disorders   
Fatigue  1  1/12 (8.33%) 
Fever w/o neutropenia  1  1/12 (8.33%) 
Edema head and neck  1  1/12 (8.33%) 
Edema limb  1  2/12 (16.67%) 
Infections and infestations   
Infection Gr0-2 neut, urinary tract  1  1/12 (8.33%) 
Investigations   
Leukocytes  1  2/12 (16.67%) 
Lymphopenia  1  1/12 (8.33%) 
Neutrophils  1  2/12 (16.67%) 
Platelets  1  4/12 (33.33%) 
Alkaline phosphatase  1  1/12 (8.33%) 
AST, SGOT  1  2/12 (16.67%) 
Bilirubin  1  1/12 (8.33%) 
Metabolism and nutrition disorders   
Hypoalbuminemia  1  1/12 (8.33%) 
Bicarbonate  1  1/12 (8.33%) 
Hypocalcemia  1  3/12 (25.00%) 
Hypophosphatemia  1  3/12 (25.00%) 
Hyponatremia  1  2/12 (16.67%) 
Musculoskeletal and connective tissue disorders   
Extremity-limb, pain  1  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/12 (8.33%) 
Cough  1  2/12 (16.67%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  1/12 (8.33%) 
Rash/desquamation  1  2/12 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEv3
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
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