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Zanubrutinib and venetoclax as initial therapy for CLL with obinutuzumab consolidation in patients with minimal residual disease positivity

Clinical Trial Details

This study is being done to improve outcomes and treatment options in patients with chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).

Patients will be treated with a combination of oral pills containing zanubrutinib and venetoclax. Depending on how each patient responds to treatment with the initial study drugs, a third drug called obinutuzumab may be added. Obinutuzumab is given by an intravenous (IV) infusion.

These study medications all are approved by the U.S. Food and Drug Administration (FDA) for CLL/SLL and for the treatment of different blood cancers. Zanubrutinib is approved as a monotherapy and venetoclax is approved in combination with obinutuzumab. However, the combination of these 3 drugs together are not FDA approved and are considered investigational. This combination has been previously combined and studied in CLL patients. 

Study participants will be treated for 15-23 consecutive 28-day cycles after which treatment will stop. The study team will discuss the specific dosing schedule with each participant.

Key Eligibility: 
  1. Open to adults over 18 years of age.
  2. Must have a confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL)    
  3. Persons of childbearing potential must be willing to comply with pregnancy prevention interventions, which will be reviewed when you contact the study team

Detailed eligibility will be discussed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2205024874

ClinicalTrials.gov:

NCT05650723

Status

Open to Enrollment

Age Group

Adult

Sponsor