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Randomized Study of Sonrotoclax + Zanubrutinib vs Venetoclax + Obinutuzumab in Pts w/ CLL

The purpose of this research study is to compare the effectiveness of two combinations of anticancer study drugs in treating your Chronic Lymphocytic Leukemia (CLL). The first combination is sonrotoclax (also known as BGB-11417) and zanubrutinib, while the second combination is venetoclax and obinutuzumab. The aim is to determine which combination of study drugs is more effective in controlling your specific type of cancer,

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

This study aims to treat your cancer and closely resembles routine care that would be received regardless of participating on a research study. To participate on the study, you will frequently meet with a member of the study team in addition to your oncology care team. The study involves: • Assessments and tests: Measurement of your height, weight, and vital signs (blood pressure, pulse, and temperature); Complete physical examination, Blood sample collection; pregnancy blood test (if applicable); Electrocardiograms (ECG); An echocardiogram (ECHO), multigated acquisition scan (MUGA) or gated heart pool scan (GHPS) scan to check your heart function; Computerized tomography (CT) scan(s) to assess your CLL disease; bone marrow biopsies • Study medications; questionnaires.

Incentives

study medication, procedure...

In-person visits:
up to 18
Total length of participation:
up to 5 years

Looking for Specific Volunteers

Able to participate:

  • You have not received treatment for your chronic lymphocytic leukemia (CLL)
  • You have been diagnoses with Chronic Lymphocytic Leukemia and told that you require treatment for it.
  • If you are a woman of childbearing potential, you agree to use a highly effective method of birth control while on treatment and in follow
  • If you are a male, you agree to use of a highly effective form of birth control while on treatment and in follow up.

Not eligible if:

  • You have previously been treated for your Chronic Lymphocytic Leukemia (CLL).
  • You have a history of active autoimmune disease.
  • You are Pregnant or nursing
  • You have Positive HIV serology (HIVAb) status or serologic status reflecting active hepatitis B or C infection

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Deborah Stephens
Medicine-Hematology

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Leukemia, Lymphoma)

IRB Number

24-0196

ClinicalTrials.gov

NCT06073821

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Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH.  This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

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