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

Completed · Phase 2 · Has a placebo group

Conditions studied: Leukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

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.

Key facts

Study ID

NCT02910583

Run by

Pharmacyclics LLC.

People needed

323

Starts

2016-09-28

Expected to finish

2024-03-27

Last updated by the study team

2024-12-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• City of Hope /ID# 1142-0047 — Duarte, California, United States
• Moores Cancer Center at UC San Diego /ID# 1142-0241 — La Jolla, California, United States
• UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 1142-0008 — Orange, California, United States
• Norton Cancer Center /ID# 1142-0071 — Louisville, Kentucky, United States
• Rutgers Cancer Institute of New Jersey /ID# 1142-1193 — New Brunswick, New Jersey, United States
• Northwell Health/Long Island Jewish Hospital /ID# 1142-0350 — New Hyde Park, New York, United States
• New York Presbyterian Hospital/Weill Cornell Med College /ID# 1142-0200 — New York, New York, United States
• University of Rochester Cancer Center /ID# 1142-0127 — Rochester, New York, United States
• Charlotte-Mecklenberg Hospital, Carolinas Healthcare System, Levine Cancer Inst /ID# 1142-0733 — Charlotte, North Carolina, United States
• Cleveland Clinic Foundation /ID# 1142-0739 — Cleveland, Ohio, United States
• University of Pennsylvania /ID# 1142-0069 — Philadelphia, Pennsylvania, United States
• Tennessee Oncology - Chattanooga /ID# 1142-0123 — Chattanooga, Tennessee, United States
• MD Anderson Cancer Center /ID# 1142-0032 — Houston, Texas, United States
• Swedish Cancer Institute /ID# 1142-0114 — Seattle, Washington, United States
• St George Hospital /ID# 1142-0654 — Kogarah, New South Wales, Australia
• Flinders Medical Centre /ID# 1142-0163 — Bedford Park, South Australia, Australia
• Monash Medical Centre /ID# 1142-0556 — Clayton, Victoria, Australia
• Peter MacCallum Cancer Centre-East Melbourne /ID# 1142-0633 — East Melbourne, Victoria, Australia
• St Vincent's Hospital Melbourne /ID# 1142-0501 — Fitzroy, Victoria, Australia
• Frankston Hospital /ID# 1142-0715 — Frankston, Victoria, Australia
• Austin Health /ID# 1142-0170 — Heidelberg, Victoria, Australia
• Ospedale San Raffaele IRCCS /ID# 1142-0523 — Milan, Lombardy, Italy
• Ospedale Policlinico San Martino /ID# 1142-0903 — Genova, Italy
• ASST Grande Ospedale Metropolitano Niguarda /ID# 1142-0581 — Milan, Italy
• Azienda Ospedaliero-Universitaria di Modena /ID# 1142-0524 — Modena, Italy

Full record on ClinicalTrials.gov

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