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A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients with Chronic Lymphocytic Leukemia (CLL)

Clinical Trial Details

The proposed trial will establish the standard of care for initial therapy of older adults with CLL. It also has the potential to diminish drug costs significantly for patients who attain BM MRD status and can go off therapy. Data regarding discontinuation of ibrutinib is applicable to the relapsed setting, as well as other diseases where ibrutinib is used. 

Key Eligibility: 

1. CLL diagnosis
Patients must have been diagnosed with CLL and have > 5000 B-cells per uL of peripheral blood at any point during the course of their disease. 

2. Patients must meet criteria for treatment as defined by 2018 IWCLL guidelines[16], which includes at least one of the following criteria.

  • Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia)
  • Massive (≥6 cm below the costal margin), progressive or symptomatic splenomegaly 
  • Massive nodes (≥10 cm) or progressive or symptomatic lymphadenopathy 
  • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy 
  • Symptomatic or functional extranodal involvement (e.g. skin, kidney, lung, spine) 
  • Constitutional symptoms, which include any of the following: Unintentional weight loss of 10% or more within 6 months; Significant fatigue; Fevers >100.5 degrees F for 2 weeks or more without evidence of infection 
  • Night sweats ≥1 month without evidence of infection 

3. Prior treatment 
Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids). Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Rita Vaccaro, RN
(212) 746-0702
rig9021@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1905020179

ClinicalTrials.gov:

NCT03737981

Sponsor:

A041702

Status

Open to Enrollment

Age Group

Adult

Sponsor