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-FI
• 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: 2019-11-04
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• 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 = 50 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

NA

Study & Design

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