Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Gleevec (Imatinib Mesylate) in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma|
- 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). ]
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.
- 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). ]
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.
- 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. ]Overall survival is defined as the time from study entry to death or date last known alive.
|Study Start Date:||June 2008|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: Imatinib mesylate
Other Name: Gleevac
Primary Objective To evaluate the overall response rate
Secondary Objectives To assess the safety and tolerability To assess the duration of response To assess the progression free survival and overall survival
This trial will use a single stage design to differentiate a >/= 25% response rate from a </= 5% rate. If observed data is consistent with the alternative response rate of 25%, imatinib would be deemed clinically interesting and worthy of a larger phase II study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684411
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Eric Jacobsen, MD||Dana-Farber Cancer Institute|