Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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.

Imatinib mesylate

Eric Jacobsen, MD

The purpose of this research study is to evaluate the overall response rate to imatinib mesylate in participants with relapsed or refractory T cell non-Hodgkin's lymphoma. This drug has been used in chronic myeloid leukemia and information from those other research studies suggests that it may help to treat T cell non-Hodgkin's lymphoma.

OBJECTIVES:

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

STATISTICAL DESIGN:

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.

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

A Pilot Study of Gleevec (Imatinib Mesylate) in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma

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.

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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 is defined as the time from study entry to death or date last known alive.

Brigham and Women's Hospital

Novartis

Dana-Farber Cancer Institute

Principal Investigator

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.

Age, Continuous

Gender

United States

Region of Enrollment

Low-Intermediate

High-Intermediate

High

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.

International Prognostic Index (IPI)

The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.

Overall Response Rate

Progression-Free Survival

Overall Survival

Overall Study

Spots Global Cancer Trial Database for Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial