PATIENTS WITH PERIPHERAL T-CELL LYMPHOMA (PTCL) MedDRA version: 16.1 Level: PT Classification code 10002230 Term: Anaplastic large cell lymphoma T- and null-cell types refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: DASATINIB
CAS Number: 302962-49-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
AOU di Bologna, Policlinico S.Orsola-Malpighi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed of PTCL (any subtype according to the REAL/WHO classification), expressing PDGFRA, with one of the following: a. have relapsed at least 1 month after conventional cytoreductive chemotherapy, or, b. are refractory to at least 1 month of cytoreductive chemotherapy, or c. are, for whatever reason, not considered candidates for therapy with conventional cytoreductive chemotherapy. 2. Not a candidate for allogeneic bone marrow transplantation. 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 =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Lack of recovery from the acute toxic effects of previous chemotherapy (to CTCAE grade >1) with the exception of chemotherapy-induced alopecia. 2. Treatment with any investigational agent within 4 weeks prior to study therapy. 3. Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure. 4. 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 and/or known positivity for Hepatitis B (core) and/or HCV (patients who are negative by PCR are eligible). d. Grade 3 or 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. Presence of any other incurable malignancy. h. Pregnancy or breast-feeding. i. Malabsorption syndromes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of clinical responses in the clinical setting of relapsed/refractory peripheral T-cell lymphomas expressing PDGFRA.;Secondary Objective: To asses safety and tolerability of dasatinib in the clinical setting of relapsed/refractory peripheral T-cell lymphomas expressing PDGFRA. Identification of clinico-pathological correlates with treatment response. Assessment of the clinical response duration and of patients’ survival ;Primary end point(s): Assessment of clinical response in terms of complete remission, partial remission, stable disease;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Assessment of toxicity in terms of type, frequency, severity, timing, and relatedness to the investigational treatment of adverse events (AE), by using the NCI CTCAE v 4.0 during the entire study period. 3. Assessment of clinico-pathological features related to treatment response assessed by gene expression profiling and gene sequencing. 4. Overall survival using Kaplan-Meier estimate (OS) at 12th month. 5. Progression free survival using Kaplan-Meier estimate (PFS) at 12th month ;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactU.O.Ematologia (P.I. Pier Luigi Zin
AOU di Bologna, Policlinico S.Orsola-Malpighi
Outcome results
None listed