A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects with T-Cell Prolymphocytic Leukemia

Phase 2

Completed

Conditions: Rare & aggressive T-lymphoid malignancy
T-Cell Prolymphocytic Leukemia
10024324

Registration Number: NL-OMON50080

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 4

Inclusion Criteria

- Male or female subjects, at least 18 years old, with a diagnosis of R/R T-PLL
that requires treatment and suitable for oral administration of study drugs.
- Subjects should meet the following disease activity criteria: an Eastern
Cooperative Oncology Group performance status <= 2.
- Subjects should have laboratory values meeting the following criteria:
• Alanine aminotransferase/aspartate aminotransferase <= 3 × the upper limit of
normal (ULN);
• Adequate liver function as indicated by a total bilirubin <= 1.5 x ULN
(subjects with documented Gilbert's syndrome may have bilirubin > 1.5 × ULN)
• Absolute neutrophil count > 1000/µL;
• Platelet count > 50,000/µL;
• Creatinine clearance >= 50 mL/minute; and
• Hemoglobin > 8 g/dL.

Exclusion Criteria

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the ORR which is defined as the proportion of subjects<br /><br>achieving CR, CRi, or PR as their best response (per investigator assessment)<br /><br>in R/R subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key secondary endpoints are as follows:<br /><br>• PFS<br /><br>• Duration of response<br /><br>• Time-to-progression<br /><br>• Overall survival<br /><br>• Number of eligible subjects reaching autologous or allogeneic transplant<br /><br>• Event-free survival<br /><br>• Disease Control rate</p><br>