Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma
- Sponsor
- Fondazione Italiana Linfomi - ETS
- Study ID
- NCT03552692
- Phase
- PHASE2
- Status
- Terminated
Conditions
- T-Cell Lymphoma Refractory
- T-Cell Lymphoma Relapsed
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Venetoclax — DRUGVenetoclax (ABT-199) will be administered orally (800 mg daily). Patients will receive ABT-199 until disease progression, unacceptable toxicity, withdrawal of consent and/or the investigator determines that further therapy is not in the patient's best interest. Tumor Lysis Syndrome (TLS) is an important identified risk for Venetoclax in oncology studies. Since there are no available data on the risk of TLS in PTCL, the risk of TLS development should be closely monitored during the study. to avoid TLS ABT-199 will be administered according the following ramp up: W eek 1 day 1: 20 mg W 1 day 2-3: 50 mg W 1 day 4-7: 100 mg W 2: 200 mg W 3: 400 mg W 4 and following: 800 mg
Study Details
The FIL\_VERT study is a phase II, open label, multicenter clinical trial. The primary of objective of the Study is to evaluate the efficacy of Venetoclax ABT-199/GDC-0199) in terms of overall response rate (ORR) in patients with relapsed/refractory BCL-2 positive peripheral T cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal T-cell lymphomas of T-follicular helper origin (TFH)
Key Dates
- Start date
- Sep 25, 2018
- Status verified
- Dec 2023
- Primary completion
- Mar 4, 2020
- Completion
- Feb 17, 2023
Study Design
- Enrollment
- 22 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ARM1 - Venetoclax (ABT-199)Venetoclax (ABT-199) will be administered orally at the dose of 800 mg once daily. Response evaluation will be performed initially after 3 cycles from the beginning of treatment with ABT-199 and then every 3 cycles during the first 12 cycles, every 4 cycles from cycle 13 to 24; for those patients still on therapy after 24 cycles, the response evaluation, after this time, will be performed every 6 cycles.
Primary Outcome Measure
Overall response rate (ORR) [ Time Frame: After the first 3 cycles (each cycle is 28 days) ]