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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Novartis | INDUSTRY |
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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 \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib mesylate | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib mesylate | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | 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. . | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Jacobsen, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25012943 | Result | Jacobsen E, Pozdnyakova O, Redd R, Fisher DC, Dorfman DM, Dal Cin P, LaCasce A, Armand P, Hochberg E, Cote G, Shahsafaei A, Neuberg D, Brown JR, Freedman AS. Imatinib mesylate lacks efficacy in relapsed/refractory peripheral T cell lymphoma. Leuk Lymphoma. 2015 Apr;56(4):993-8. doi: 10.3109/10428194.2014.941835. Epub 2014 Aug 20. |
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12 participants were enrolled between August 2008 and December 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate | 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. . | The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma. | Posted | Number | 90% Confidence Interval | proportion of participants | 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). |
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAEv3 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAEv3 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Jacobsen, MD | Dana-Farber Cancer Institute | 617.632.6633 | EDJACOBSEN@PARTNERS.ORG |
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| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| 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). |
| Overall Survival | Overall survival is defined as the time from study entry to death or date last known alive. | 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. |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| International Prognostic Index (IPI) | 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. | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
|
|
| Secondary | Progression-Free Survival | 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. | The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma. | Posted | Median | 90% Confidence Interval | days | 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). |
|
|
|
| Secondary | Overall Survival | Overall survival is defined as the time from study entry to death or date last known alive. | The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma. | Posted | Median | 90% Confidence Interval | days | 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. |
|
|
|
| 5 |
| 12 |
| 10 |
| 12 |
| Leukocytes | Investigations | CTCAEv3 | Systematic Assessment |
|
| Lymphophenia | Investigations | CTCAEv3 | Systematic Assessment |
|
| Neutrophils | Investigations | CTCAEv3 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAEv3 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAEv3 | Systematic Assessment |
|
| Rash/Desquamation | Skin and subcutaneous tissue disorders | CTCAEv3 | Systematic Assessment |
|
| Cardiac | Cardiac disorders | CTCAEv3 | Systematic Assessment |
|
| Vision-blurred | Eye disorders | CTCAEv3 | Systematic Assessment |
|
| Vision-flashing lights/floaters | Eye disorders | CTCAEv3 | Systematic Assessment |
|
| Ocular | Eye disorders | CTCAEv3 | Systematic Assessment |
|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAEv3 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAEv3 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAEv3 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAEv3 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAEv3 | Systematic Assessment |
|
| Fever w/o neutropenia | General disorders | CTCAEv3 | Systematic Assessment |
|
| Edema head and neck | General disorders | CTCAEv3 | Systematic Assessment |
|
| Edema limb | General disorders | CTCAEv3 | Systematic Assessment |
|
| Infection Gr0-2 neut, urinary tract | Infections and infestations | CTCAEv3 | Systematic Assessment |
|
| Leukocytes | Investigations | CTCAEv3 | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAEv3 | Systematic Assessment |
|
| Neutrophils | Investigations | CTCAEv3 | Systematic Assessment |
|
| Platelets | Investigations | CTCAEv3 | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAEv3 | Systematic Assessment |
|
| AST, SGOT | Investigations | CTCAEv3 | Systematic Assessment |
|
| Bilirubin | Investigations | CTCAEv3 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAEv3 | Systematic Assessment |
|
| Bicarbonate | Metabolism and nutrition disorders | CTCAEv3 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAEv3 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAEv3 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAEv3 | Systematic Assessment |
|
| Extremity-limb, pain | Musculoskeletal and connective tissue disorders | CTCAEv3 | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAEv3 | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAEv3 | Systematic Assessment |
|
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| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |