New Investigation Oral Drug for Previously Treated CLL/SLL Patients

Trial ID:
Marin Xavier, MD
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.

Inclusion Criteria

Patients must:
  • 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

Exclusion Criteria

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

Additional Info

  • 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

Contact Info:

  • Clinical Research Services