A Study to Evaluate the Efficacy of Venetoclax plus Ibrutinib in Participants With T-Cell Prolymphocytic Leukemia

Phase 1

• Conditions: T-Cell Prolymphocytic Leukemia; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002179-17-GB
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-05
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 37

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 = 30 mL/minute; and
• Hemoglobin > 8 g/dL.

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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the efficacy in subjects with T-PLL treated with venetoclax plus ibrutinib;Secondary Objective: - To assess safety and tolerability in subjects with T-PLL treated with venetoclax plus ibrutinib,<br>- To assess the ability of the subset of transplant-naïve subjects to proceed to further autologous/allogeneic stem cell transplantation (assessed by number of eligible subjects reaching transplant), <br>;Primary end point(s): The primary endpoint is the ORR which is defined as the proportion of subjects achieving CR, CRi, or PR as their best response (per investigator assessment) in R/R subjects.;Timepoint(s) of evaluation of this end point: When all subjects in Stage 1 complete the 24-week disease assessment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Key secondary endpoints are as follows:<br>• PFS<br>• Duration of response<br>• Time-to-progression<br>• Overall survival<br>• Number of eligible subjects reaching autologous or allogeneic transplant<br>• Event-free survival;Timepoint(s) of evaluation of this end point: When all subjects in Stage 1 complete the 24-week disease assessment.<br>