Study of Venetoclax (ABT-199) Added to Ibrutinib in Patients With High-Risk Chronic Lymphocytic Leukemia (CLL)
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|ClinicalTrials.gov Identifier: NCT03128879|
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : September 13, 2018
The goal of this clinical research study is to learn if giving the drug venetoclax with ibrutinib can help to control the disease in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The safety of this combination treatment will also be studied.
This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of CLL/SLL. Venetoclax is FDA approved for some patients with CLL whose disease has come back after 1 or more previous treatments. The use of venetoclax in combination with ibrutinib is considered investigational.
The study doctor can describe how the study drugs are designed to work.
Up to 45 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Primary Lymphoid Haematopoietic Neoplasms Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma||Drug: Venetoclax Drug: Ibrutinib Drug: Allopurinol||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Venetoclax (ABT-199) Added to Ibrutinib in Patients With High-Risk Chronic Lymphocytic Leukemia (CLL)|
|Actual Study Start Date :||June 16, 2017|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2023|
Experimental: Venetoclax + Ibrutinib
Participants receive Ibrutinib and Venetoclax by mouth once per day.
Participants take Venetoclax by mouth on Day 1 of Cycle 1 and dose-escalate according to the following schedule:
i) Day 1 - Venetoclax 20 mg daily. ii) Day 8 - Venetoclax 50 mg daily. iii) Day 15 - Venetoclax 100 mg daily. iv) Day 22 - Venetoclax 200 mg daily. v) Day 29 - Venetoclax 400 mg daily and continuously thereafter.
Participants receive Ibrutinib by mouth up to 420 mg per day.
Allopurinol 300 mg/day by mouth beginning at least 72 hours prior to Venetoclax dose.
- Overall Response (OR) [ Time Frame: 48 weeks ]OR defined as a complete response (CR) or partial response (PR) or CR with incomplete marrow recovery (CRi) as determined by investigator assessment using IWCLL 2008 response criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128879
|Contact: Philip A. Thompson, MBBSfirstname.lastname@example.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Philip A. Thompson, MBBS||M.D. Anderson Cancer Center|