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Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)

NCT02910583

CompletedPhase 2

Sponsor: Pharmacyclics LLC.

Conditions: Leukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Interventions: ibrutinib, venetoclax, Placebo

Countries: United States, Australia, Italy, New Zealand, Poland, Spain

This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Diagnosis of CLL/SLL that meets 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria (Hallek et al), with active disease meeting at least 1 IWCLL criteria for requiring treatment.
* Measurable nodal disease by computed tomography (CT)
* Adequate hepatic, and renal function
* Adequate hematologic function
* absolute neutrophil count \>750/µL
* platelet count \>30,000 /μL
* hemoglobin \>8.0 g/dL

Exclusion Criteria:

* Any prior therapy used for treatment of CLL/SLL
* Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for tumor lysis syndrome (TLS)
Locations (46)
  • Duarte, California, United States
  • La Jolla, California, United States
  • Orange, California, United States
  • Louisville, Kentucky, United States
  • New Brunswick, New Jersey, United States
  • New Hyde Park, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Charlotte, North Carolina, United States
  • Cleveland, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Chattanooga, Tennessee, United States
  • Houston, Texas, United States
  • Seattle, Washington, United States
  • Kogarah, New South Wales, Australia
  • Bedford Park, South Australia, Australia
  • Clayton, Victoria, Australia
  • East Melbourne, Victoria, Australia
  • Fitzroy, Victoria, Australia
  • Frankston, Victoria, Australia
  • Heidelberg, Victoria, Australia
  • Milan, Lombardy, Italy
  • Genova, Italy
  • Milan, Italy
  • Modena, Italy
  • Novara, Italy
  • Padova, Italy
  • Piacenza, Italy
  • Otahuhu, Auckland, New Zealand
  • Christchurch, Canterbury, New Zealand
  • + 16 more on CT.gov