A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
Start Date
1/23/2025
Completion Date
11/30/2032
Summary
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
Detailed Description
This study will test the safety of novel sonrotoclax dosing with gradual increases of sonrotoclax dose over specified periods until the intended target daily dose is reached. The focus will be on tumor lysis syndrome (TLS) and related toxicity signals. Sonrotoclax is a drug that works by blocking a protein called B-cell lymphoma-2 (BCL-2). When sonrotoclax blocks BCL-2 it slows down or stops the growth of tumor cells and helps them die. This can lead to improvements in patients with certain malignant diseases including chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). The start of treatment with BCL-2 inhibitor requires a gradual ramp-up over the first weeks to avoid potential consequences of initial tumor cell breakage and the release of cell content in the bloodstream. Several ramp-up schedules have already been explored, and this study aims to optimize the dosing ramp-up schedule that may be beneficial to patients and caregivers. Zanubrutinib is a commercialized product that works by blocking a protein called Bruton's tyrosine kinase (BTK) and controlling the activity and survival of malignant B cells. Zanubrutinib has received approval in over 65 countries/regions worldwide for the treatment of adult participants with B-cell malignancies, including CLL and MCL. This study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 17 months for treatment-naïve (TN) CLL participants or approximately 32 months for relapsed/refractory (R/R) MCL participants.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Sonrotoclax
Zanubrutinib
Conditions
Locations
Moffitt Cancer Center
Tampa, Florida 33612-9496
United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804
United States
The University of Kansas Cancer Center
Westwood, Kansas 66205-2003
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215-5418
United States
Washington University School of Medicine
St Louis, Missouri 63110-1010
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-4433
United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales NSW 2148
Australia
Genesiscare St Andrews
Adelaide, South Australia SA 5000
Australia
Cabrini Hospital Malvern
Malvern, Victoria VIC 3144
Australia
The Alfred Hospital
Melbourne, Victoria VIC 3004
Australia
Rockingham Hospital
Cooloongup, Western Australia WA 6168
Australia
Linear Clinical Research
Nedlands, Western Australia WA 6009
Australia
Chu Dijon
Dijon, 21000
France
Chu Montpellier Hopital Saint Eloi
Montpellier, 34090
France
Iuct Oncopole
Toulouse, 31100
France
Queen Elizabeth Hospital
Birmingham, B15 2TH
United Kingdom
St Jamess University Hospital
Leeds, LS9 7TF
United Kingdom