A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.

Description

The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.

Conditions

Chronic Lymphocytic Leukemia, CLL

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Study Overview

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Study Details

Study overview

The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.

A Phase 1/2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.

A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.

Condition
Chronic Lymphocytic Leukemia
Intervention / Treatment

-

Contacts and Locations

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612-9497

Fort Wayne

Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States, 46804

Westwood

The University of Kansas Cancer Center, Westwood, Kansas, United States, 66205

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

Seattle

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Stable ECOG Performance Status ≤ 2.
  • 2. Adequate organ function and no very recent transfusion or blood growth factor
  • 3. Participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 90 days after the last dose of sonrotoclax or ≥ 30 days after the last dose of zanubrutinib, whichever is later.
  • 4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease
  • 5. At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.
  • 1. Participants unable to comply with the requirements of the protocol
  • 2. Serologic status reflecting active viral HBV or HCV infection
  • 3. Positive HIV serology (HIVAb) status unless certain conditions are met.
  • 4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment
  • 5. Prior systemic treatment for the CLL
  • 6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2027-12-31