Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia (NCT03737981)
🩺 Plain-English Summary (8th-Grade Level)
This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia who have not received previous treatment. The addition of venetoclax to the usual treatment might prevent chronic lymphocytic leukemia from returning. This trial also will investigate whether patients who receive ibrutinib plus obinutuzumab plus venetoclax and have no detectable chronic lymphocytic leukemia after 1 year of treatment, can stop taking ibrutinib. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (42 items) and avoid the listed exclusions (13 items).
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients must not have had prior therapy for CLL/SLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)
- Patients must not have any history of Richter's transformation or prolymphocytic leukemia (prolymphocytes in blood \> 55%)
- Patients with class III or class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible
- Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible
- Patients must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study
- Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not allowed on this study. Patients on strong CYP3A inhibitors must discontinue the drug for 14 days prior to registration on the study
- Chronic concomitant treatment with strong CYP3A4/5 inducers is not allowed. Patients must discontinue the drug 14 days prior to registration on the study
- Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily
- Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics
- Patients must not have a known allergy to mannitol
- Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (857 Sites)
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- Anchorage Associates in Radiation Medicine — Anchorage, Alaska
- Anchorage Radiation Therapy Center — Anchorage, Alaska
- Alaska Breast Care and Surgery LLC — Anchorage, Alaska
- Alaska Oncology and Hematology LLC — Anchorage, Alaska
- Alaska Women's Cancer Care — Anchorage, Alaska
- Anchorage Oncology Centre — Anchorage, Alaska
- Katmai Oncology Group — Anchorage, Alaska
- Providence Alaska Medical Center — Anchorage, Alaska
- Fairbanks Memorial Hospital — Fairbanks, Alaska
- Kingman Regional Medical Center — Kingman, Arizona
- Cancer Center at Saint Joseph's — Phoenix, Arizona
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona
- University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona
- Banner University Medical Center - Tucson — Tucson, Arizona
- University of Arizona Cancer Center-North Campus — Tucson, Arizona
- Mercy Hospital Fort Smith — Fort Smith, Arkansas
- CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas
- John L McClellan Memorial Veterans Hospital — Little Rock, Arkansas
- Kaiser Permanente-Anaheim — Anaheim, California
- Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
- PCR Oncology — Arroyo Grande, California
- Kaiser Permanente-Baldwin Park — Baldwin Park, California
- Kaiser Permanente-Bellflower — Bellflower, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.