M18-803: Venetoclax & Ibrutinib in T-PLL
Research type
Research Study
Full title
A Prospective, Open-Label, Single Arm, Phase 2, Multi-Center Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects with T-cell Prolymphocytic Leukemia
IRAS ID
268449
Contact name
Natalia Tomkiewicz
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2018-002179-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Research Summary
T-Cell Prolymphocytic Leukaemia (T-PLL) is a rare type of leukaemia (cancer of blood cells) in adults and it is more common in men than in women. The average age of T-PLL diagnosis is 61. There are limited treatment options for patients and currently, no cure exists. Current treatment guidelines recommend exploring clinical trials whenever possible. However, there are only a few ongoing drug trials for patients with T-PLL, worldwide.
This study will include patients who have received no treatment or whose T-PLL has not improved or has relapsed after previous treatment. All patients in this study will receive venetoclax and ibrutinib. This study evaluates the efficacy (how well the drugs work together) and safety of this combination. Venetoclax kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. Ibrutinib blocks a protein which signals cancer cells to multiply. Venetoclax and ibrutinib are currently approved in the United States and Europe for other types of blood cancers.
All patients will receive a starting dose of 20 mg (venetoclax) and 420 mg (ibrutinib) daily. The dose of venetoclax will be gradually increased over 5 days up to the daily dose of 400 mg. Patients can take both drugs for 2 years (or, possibly longer, for patients who are responding well). After this, they will be followed up for 2 years. The patients may be on the study for 4 years with approximately 22 visits to the study site. AbbVie is funding this study which will take place at roughly 20 hospitals and will enrol up to 37 patients.
The effect of the treatment on T-PLL will be checked by taking blood, bone marrow samples, performing physical exams, ECG, computed tomography scans and by measuring side effects.
Summary of Results
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REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/0417
Date of REC Opinion
1 Jun 2020
REC opinion
Further Information Favourable Opinion