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This is a phase 3 open-label, randomized study to assess the safety and effectiveness of a fixed duration of the investigational study drug plus standard of care treatment versus standard care alone.
- Trial ID:
- Marin Xavier, MD
- Have confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma
- Have been previously treated with at least one line of therapy
- Be agreeable to a screening bone marrow biopsy
- Have one of the following:
- --Development of, or worsening of, anemia and/or thrombocytopenia
- --Massive or progressive or symptomatic splenomegaly (> 13 cm)
- --Massive nodes or progressive or symptomatic lymphadenopathy
- --Progressive lymphocytosis with an increase of > 50% over a 2-month period or lymphocyte doubling time < 6 months
- --Autoimmune complications including anemia or thrombocytopenia poorly responsive to corticosteroids
- --Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine)
- --Unintentional weight loss = 10% within the previous 6 months
- --Significant fatigue
- --Fevers of 100.4°F (38.0°C) or higher for 2 or more weeks without evidence of infection
- --Night sweats for 1 month or more without evidence of infection
Patients must not:
- Have known Richter's Transformation, Prolymphocytic Leukemia, or Hodgkin's Lymphoma
- Have previous exposure to Venetoclax or other BCL2 inhibitors
- Be prescribed Warfarin or other Vitamin K antagonist
- Have Central Nervous System involvement
- Have had any major bleeding on previous BTK inhibitor
- Have an active second malignancy
- Have previously received allogenic or autologous SCT or CAR-T therapy in the last 60days
- Be pregnant or planning on becoming pregnant
- Patients will be randomized (like the flip of coin) to standard of care plus the investigational drug or standard of care alone.
- Consumption of grapefruit, grapefruit juice, Seville oranges, and Starfruit is prohibited during the study.
- For more information search for NCT04965493 at www.clinicaltrials.gov