ACTIVE_NOT_RECRUITING

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

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Conditions

Chronic Lymphocytic LeukemiaCLLCLL previously untreatedHematological Malignancies

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-23
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06697184

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Stable ECOG Performance Status ≤ 2.
  2. 2. Adequate organ function and no very recent transfusion or blood growth factor
  3. 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. 4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease
  5. 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. 1. Participants unable to comply with the requirements of the protocol
  2. 2. Serologic status reflecting active viral HBV or HCV infection
  3. 3. Positive HIV serology (HIVAb) status unless certain conditions are met.
  4. 4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment
  5. 5. Prior systemic treatment for the CLL
  6. 6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment

Contacts and Locations

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-23
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-01-23
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • CLL previously untreated
  • Hematological Malignancies

Additional Relevant MeSH Terms

  • Chronic Lymphocytic Leukemia
  • CLL