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Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma

NCT03552692 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-12-12

No results posted yet for this study

Summary

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)

Conditions

  • T-Cell Lymphoma Relapsed
  • T-Cell Lymphoma Refractory

Interventions

DRUG

Venetoclax

Venetoclax (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

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Francesco Zaja, MD · Azienda Sanitaria Universitaria Integrata di Trieste

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-25
Primary Completion
2020-03-04
Completion
2023-02-17

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03552692 on ClinicalTrials.gov