PERIPHERAL T-CELL LYMPHOMA PTCL EXPRESSING PDGFRA MedDRA version: 9.1 Level: LLT Classification code 10025310 Term: Lymphoma
Conditions
Interventions
Trade Name: GLIVEC 120CPS 100MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Imatinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of PTCL expressing PDGFRA, in patients who - have relapsed or are refractory to conventional therapy, - are, for whatever reason, not considered candidates for other alternative therapy. 2. Age 18 years or greater. 3. ECOG Performance score of 0, 1, 2 or 3 Karnofsky Performance Score 40 . 4. Life expectancy 4 weeks. 5. Adequate hepatic and renal function, as defined by serum transaminases 2.5x ULN,bilirubin 1.5x ULN, and creatinine 1.5x ULN. 6. Post-menopausal, surgically sterile, or taking effective contraception in female patients. 7. Documentation of written informed consent to participate in the trial. 8. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Treatment with any investigational agent within 3 weeks prior to study therapy. 2. Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to a. Presence of central nervous system CNS lymphoma. b. Active uncontrolled bacterial infection. c. Known human immunodeficiency virus HIV infection. d. Grade 4 bleeding. e. Significant cardiovascular disease i.e., uncontrolled arrhythmias, unstable angina , or a major thromboembolic event myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis in the last 6 months. f. Patients with known adrenal insufficiency. g. Pregnancy or breast-feeding. h. Malabsorption syndromes ecc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Assessment of safety and tolerability of imatinib mesylate 400 mg bid in the clinical setting of peripheral T-cell lymphomas PTCL ; - Assessment of clinical responses defined as disease stabilization DS , partial remission PR , and complete remission CR .;Secondary Objective: - Assessment of the response duration in terms of progression free survival PFS - Assessment of the response duration in terms of overall survival OS ;Primary end point(s): - The primary end-point is the rate of clinical response partial and complete responses PR and CR in all patients. | — |
Countries
Italy
Outcome results
None listed