A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Pl… (NCT02970318) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
United States310 participantsStarted 2017-02-02
Plain-language summary
This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women ≥ 18 years of age.
✓. ECOG performance status of 0 to 2.
✓. Diagnosis of CLL that meets published diagnostic criteria (Hallek 2008):
✓. Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co-expressing ≥ 1 B-cell marker (CD19, CD20, or CD23) and CD5.
✓. Prolymphocytes may comprise ≤ 55% of blood lymphocytes.
✓. Presence of ≥ 5 x 10\^9 B lymphocytes/L (5000/μL) in the peripheral blood (at any point since initial diagnosis).
✓. Must have documented CD20-positive CLL.
✓. Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment:
Exclusion criteria
✕. Known CNS lymphoma or leukemia.
✕. Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
✕. Uncontrolled AIHA or ITP defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (\> 20 mg daily of prednisone or equivalent).
✕. Prior exposure to a BCL-2 inhibitor (e.g., venetoclax/ABT-199) or a BCR inhibitor (e.g., BTK inhibitors or PI3K inhibitors). Prior bendamustine is allowed if Investigator's choice for treatment in Arm B is idelalisib with rituximab. Bendamustine retreatment is allowed if the prior response to bendamustine lasted \> 24 months.
What they're measuring
1
Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment
Timeframe: IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
✕. Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug.
✕. Corticosteroid use \> 20 mg daily prednisone equivalent within 1 week before first dose of study drug, except as indicated for other medical conditions such as inhaled steroid for asthma, topical steroid use, or as premedication for administration of study drug or contrast. For example, subjects requiring steroids at daily doses \> 20 mg prednisone equivalent systemic exposure daily, or those who are administered steroids for leukemia control or white blood cell count lowering are excluded.
✕. Prior radio- or toxin-conjugated antibody therapy.
✕. Prior allogeneic stem cell transplant or prior autologous transplant within 6 months of first dose of study drug(s) or presence of graft-vs-host disease or receiving treatment for graft-vs-host disease.