New Investigation Oral Drug for Previously Treated CLL/SLL Patients
- Trial ID:
- IRB-22-7916
- Marin Xavier, MD
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 www.clinicaltrials.gov
Contact Info:
- Clinical Research Services
- CRSLeadership@scrippshealth.org