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Protocol No. EA9161

Principal Investigator Chang, Julie

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)

Objective This study is being done to answer the following question:
  • What are the good and bad effects of a time limited administration of a targeted three drug treatment combination when compared with the more standard two drug treatment combination, which requires long-term, indefinite drug administration? Time limited administration means that you will only receive treatment for a specified period of time, rather than receiving treatment indefinitely
    We are doing this study because we want to find out if this approach is better or worse than the usual approach for your untreated chronic lymphocytic leukemia(CLL) . The usual approach is defined as care most people get for chronic lymphocytic leukemia(CLL)

  • Treatment You will either get the usual therapy drugs used for this type of cancer, ibrutinib and obinutuzumab, plus a third drug used to treat CLL called venetoclax for up to 19 months OR you will get usual therapy drugs used for this type of cancer, ibrutinib and obinutuzumab, until your doctor decides your disease is getting worse or the side effects become too severe. Ibrutinib, obinutuzumab, and venetoclax are all FDA approved drugs to treat CLL, but the combination of these drugs is considered investigational

    Description A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)

    Key Eligibility
  • Diagnosis of CLL according to the NCI/IWCLL criteria or SLL according to the WHO criteria
  • No prior chemotherapy, BTK inhibitor therapy, venetoclax, small molecule signaling inhibitor, or monoclonal anti-body therapy for treatment of CLL or SLL
  • Age greater than or equal to 18 and less than 70
  • ECOG Performance status 0-2
  • No deletion of 17p13 on cytogenetic analysis by FISH
  • Glomerular filtration rate (GFR) greater than 40 mL/minute as calculated by the Cockcroft-Gault Formula
  • Total bilirubin less than or equal to 1.5 x ULN unless due to Gilbert’s disease. For those with a total bilirubin greater than 1.5 x ULN, a direct bilirubin should be performed and must be less than 1.5 mg/dL for Gilbert’s to be diagnosed
  • SGOT (AST)/SGPT (ALT) less than or equal to 3.0 x the institutional ULN
  • PT/INR less than 1.5 ULN and PTT (aPTT) less than 1.5 X ULN
  • No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment. Patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation
  • No current use of corticosteroids. EXCEPTION: Low doses of steroids less than 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical condition (e.g. chronic adrenal insufficiency) is permitted
  • No previous autoimmune complications as defined by the protocol
  • No other active primary malignancy as defined by the protocol
  • HIV positive with undetectable HIV viral load are eligible as defined by the protocol
  • Not eligible if they require treatment with a strong cytochrome P450 (CYP) 3A inhibitor as defined by the protocol
  • May not have received warfarin or another vitamin K antagonist in the preceding 30 days
  • Can not be pregnant or breastfeeding and male and female of childbearing potential must agree to adequate birth control as defined y the protocol
  • Must be able to swallow capsules
  • Can not have disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, ulcerative colitis or partial or complete bowel obstruction
  • Must not be on any other systemic immunosuppressant therapy other than corticosteroids within 28 days of the first dose of study drug
  • Must not have any known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
  • Must undergo assessment with Timed Up and Go (TUG) test and comorbidity index
  • No congestive heart failure or New York Heart Association Functional Classification III or IV congestive heart failure
  • No history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to registration
  • No cerebral vascular accident or intracranial bleed within the last 6 months
  • No infection with known chronic, active hepatitis C
  • Recent infections requiring systemic treatment
  • Has met at least one of the following indications for treatment: progressive marrow failure as manifested by the development of worsening anemia (Hg less than 11 g/dl) and/or thrombocytopenia (Platelets less than 100 x 109/L), OR symptomatic or progressive lymphadenopathy, splenomegaly, or hepatomegaly
  • One or more of the following disease-related symptoms: Weight loss greater than or equal to 10% within the previous 6 months, OR Grade 2 or 3 fatigue attributed to CLL, Fevers greater than 100.5F for 2 weeks without evidence of infection, OR clinically significant night sweats without evidence of infection
  • Progressive lymphocytosis (not due to the effects of corticosteroids) with an increase of greater than 50% over a two-month period or an anticipated doubling time of less than six months

  • Applicable Disease Sites Leukemia

    Status Open

    Participating Institutions Dean Health System, Hematology and Oncology Clinic ; UW Hospital and Clinics; UWCCC 1 South Park