OPEN LABEL, PHASE IIA MULTICENTER STUDY OF DASATINIB IN THE TREATMENT OF PATIENTS WITH PERIPHERAL T-CELL LYMPHOMA (PTCL) RELAPSED/REFRACTORY OR NOT AMENABLE TO CONVENTIONAL THERAPY-PTCL-DASA01
- Conditions
- PATIENTS WITH PERIPHERAL T-CELL LYMPHOMA (PTCL)MedDRA version: 16.1Level: PTClassification code 10002230Term: Anaplastic large cell lymphoma T- and null-cell types refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2013-005240-28-IT
- Lead Sponsor
- AOU di Bologna, Policlinico S.Orsola-Malpighi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 26
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 <2.5x ULN, bilirubin <1.5x ULN, and creatinine <1.5x ULN.
6.Age 18 years or greater.
7.Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) willing to use a double method of contraception during the study and 3 months after the end of treatment. One of these methods of contraception must be a barrier method. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months or had menses any time in the preceding 12 consecutive months. WOCBP must have a negative serum pregnancy test at baseline
8.Male patient whose sexual partner(s) are WOCBP who are willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment
9.Documentation of written informed consent to participate in the trial.
10.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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>Identification of clinico-pathological correlates with treatment response.<br>Assessment of the clinical response duration and of patients’ survival<br>;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 Outcome Measures
Name Time Method 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.<br>3.Assessment of clinico-pathological features related to treatment response assessed by gene expression profiling and gene sequencing.<br>4.Overall survival using Kaplan-Meier estimate (OS) at 12th month.<br>5.Progression free survival using Kaplan-Meier estimate (PFS) at 12th month<br>;Timepoint(s) of evaluation of this end point: 24 months