Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral … (NCT03552692) | Clinical Trial Compass
TerminatedPhase 2
Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma
Stopped: efficacy lower than expected
Italy22 participantsStarted 2018-09-25
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Histologically documented diagnosis of BCL-2 positive PTCL-NOS, AITL, TFH as defined in the 2016 edition of the World Health Organization (WHO) classification. Only patients with percentage of BCL-2 positive tu-mor cells ≥ 25% in the relapse biopsy, if available, or otherwise in the ini-tial biopsy, will be included onto the study;
* Age ≥ 18 years
* Relapsed or refractory to at least one previous standard line of treatment
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
* At least one site of measurable nodal or extranodal disease at baseline ≥ 2.0 cm in the longest transverse diameter as determined by CT scan (MRI is allowed only if CT scan cannot be performed). Note: Patients with only bone marrow involvement are eligible
* Adequate hematological counts defined as follows:
* Absolute Neutrophil count (ANC) \> 1.0 x 10\^9/L unless due to bone marrow involvement by lymphoma
* Platelet count ≥ 50.000/mm\^3 unless due to bone marrow involvement by lymphoma
* Adequate renal function defined as follows:
* Creatinine clearance ≥ 30 mL/min
* Adequate hepatic function per local laboratory reference range as follows:
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN
* Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syn-drome or of non-hepatic origin)
* Subject understands and voluntarily signs an informed consent form ap-proved by an Independent Ethics Committee (IEC)/Institutional Review Board (I…
What they're measuring
1
Overall response rate (ORR)
Timeframe: After the first 3 cycles (each cycle is 28 days)