Health Condition 1: null- patients with relapsed or refractory peripheral T-cell lymphoma
Conditions
Interventions
Intervention1: Masitinib: 6 mg/kg/day given orally twice daily
Control Intervention1: Dexamethasone: 20 mg once weekly for 3 consecutive weeks out of 4 weeks
Control Intervention2: Gemcitabine: 1000 m
Sponsors
AB Science
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient with histologically/cytologically confirmed peripheral T-cell lymphoma (PTCL), using the World Health Organisation (WHO) disease classification 2008: - Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+) - Angioimmunoblastic T-cell lymphoma - Anaplastic large cell lymphoma ALK+ - Anaplastic large cell lymphoma ALK- - Peripheral T-cell lymphoma - NOS (not otherwise specified) - Extranodal Natural Killer (NK)/T-cell lymphoma - Enteropathy-associated T-cell lymphoma - Hepatosplenic T-cell lymphoma - Subcutaneous panniculitis T-cell lymphoma - Transformed mycosis fungoides 2. Patient with documented progression of disease after at least 1 previous chemotherapy cycle 3. Patient with minimum 1 bidimensionally measurable disease (more than 1.5 cm) according the Cheson criteria 4. Patient having Ann Arbor stage IIâ??IV 5. Patient with ECOG Performance Status 6. Patients with adequate organ function - Absolute neutrophils count (ANC) >= 1.5 x 109/L, or >= 1 x 109/L in case of medullary involvement - Haemoglobin >= 10 g/dL - Platelets (PTL) >= 75 x 109/L - AST/ALT - Gamma GT - Bilirubin - Normal Creatinine or if abnormal creatinine, creatinine clearance >= 50 mL/min (Cockcroft and Gault formula) - Albumin > 1 x LLN - Proteinuria = 1+ on the dipstick, 24 hours proteinuria must be 7. Patient with life expectancy > 3 months 8. Man or woman, age >= 18 years 9. Body mass index > 18 and body weight > 40 kg 10. Man and woman of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. 11. Patient able and willing to comply with study procedures as per protocol. 12. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment. 13. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures are performed. If the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, the designated legal guardian must sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patient with: - T-cell prolymphocytic leukemia - T-cell large granular lymphocytic leukemia - Mycosis fungoides, other than transformed mycosis fungoides - Sezary syndrome - Primary cutaneous CD30+ T-cell lymphoproliferative disorders 2. Patient with central nervous involvement of lymphoma 3. Patient with previous allogeneic stem cell transplantation 4. Patient who relapsed less than three months after an autologous stem cell transplantation 5. Patient presenting with cardiac disorders defined by at least one of the following conditions: - Patient with recent cardiac history (within 6 months) of: - Acute coronary syndrome - Acute heart failure (class III or IV of the NYHA classification) - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death) - Patient with cardiac failure class III or IV of the NYHA classification - Patient with severe conduction disorders which are not prevented by permanent pacing (atrioventricular block 2 and 3, sino-atrial block) - Syncope without known aetiology within 3 months - Uncontrolled severe hypertension, according to the judgement of the investigator, or symptomatic hypertension 6. Patient with clinically uncontrolled infectious diseases and patient with Human Immunodeficiency Virus infection and/or hepatitis B or C infection 7. Patient with a history of any other malignancy within the 5 years prior to study treatment, except carcinoma in situ of the cervix or basal cell carcinoma of the skin 8. Pregnant or nursing woman 9. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent 10. Patient with known hypersensitivity to gemcitabine and/or excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS)Timepoint: Till death or lost to followup | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Progression Free Survival (PFS) ratesTimepoint: W12, W24 and then every 24 weeks;Survival ratesTimepoint: W12, W24 and then every 24 weeks;TTP rateTimepoint: W12, W24 and then every 24 weeks | — |
Countries
Algeria, Austria, China, Czech Republic, France, Greece, Hong Kong, Hungary, India, Italy, Malaysia, Russian Federation, Singapore, Slovakia, Spain, Taiwan, Thailand, Ukraine, United Kingdom
Contacts
Public ContactJhansi Reddy
Maya Clinicals Drug Development Pvt. Ltd.
Outcome results
None listed