New CLL strategy: give extra drug only to those who still have cancer cells
NCT ID NCT05650723
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a personalized approach for chronic lymphocytic leukemia (CLL). Patients first receive two oral drugs (zanubrutinib and venetoclax). Only those who still have detectable cancer cells after treatment get an additional infusion drug (obinutuzumab). The goal is to see if this strategy can clear cancer while avoiding unnecessary side effects. About 50 adults with CLL are enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zanubrutinib, venetoclax, and obinutuzumab
- What this could lead to
- If successful, this approach could reduce side effects by giving fewer drugs to more patients, while still effectively controlling CLL.
- What could go wrong
- This is a small, early-phase trial (50 people) with no control group. The strategy may not work for everyone, and side effects from the drugs are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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50 people
The number who actually took part.
- Started
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May 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Subject must be able to voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures. 2. Subject must be ≥ 18 years of age. 3. Subject must have confirmed diagnosis of CLL/SLL based upon 2018 iwCLL Guidelines. a. Please note, participants with SLL must have identifiable B-cells in peripheral blood or bone marrow consistent with CLL/SLL immuno-phenotype, based on flow-cytometry, in order to be enrolled 4. Subject must have indications for treatment per the 2018 iwCLL Guidelines. 5. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2. 6. Subject must have adequate organ function defined as: 1. Creatinine clearance ≥ 30 mL/min (as estimated by the Cockcroft-Gault equation or the Modification of Diet in Renal Disease equation, or as measured by nuclear medicine scan or 24-hour urine collection). 2. Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase, and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase ≤ 2.5 × upper limit of normal (ULN) unless due to CLL/SLL. 3. Serum total bilirubin \< 3.0 × ULN (unless documented Gilbert's syndrome) 7. Subject must have adequate bone marrow function and meet the below thresholds unless approved by sponsor if cytopenias are felt to be due to significant marrow involvement of CLL: 1. Absolute neutrophil count ≥ 1.0 x103/μL 2. Hemoglobin ≥ 7 g/dL (can be transfused up to 1 week prior to study enrollment) 3. Platelets ≥ 75,000 cells/μL OR platelets ≥ 30,000 cells/μL if clearly due to disease under study (per investigator discretion) 8. Subjects of childbearing potential must be willing to comply with pregnancy prevention interventions (as defined in Section 4.4) Exclusion Criteria A subject will be ineligible for the study if he/she meets the following criteria: 1. Previous exposure to any systemic anti-cancer therapy as a treatment for CLL/SLL, including but not limited to chemotherapy, immunotherapy, radiotherapy, hormone therapy (other than contraceptives, hormone-replacement therapy or megestrol acetate) or investigational therapy. 2. Subject with a history of malignancy except for non-melanoma skin cancers. Subjects treated with curative intent via methods of local resection and or locally targeted anticancer treatment and are free of malignancy for at least 35 years from treatment end will be allowed to enroll. Adjuvant hormonal therapy will be allowed at time of enrollment if the subject otherwise is not excluded by the 3-year waiting period. 3. Subject requires chronic immunosuppressive therapy for any reason or was treated with immunosuppressive therapy within 6 months of study entry. 4. Subjects with active autoimmune hemolytic anemia or immune thrombocytopenia purpura. 5. Subject with prolymphocytic leukemia or Richter's Transformation. 6. Active bleeding, or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease). 7. Subject requires warfarin or equivalent vitamin K antagonist. 8. Uncontrolled or active significant infection requiring systemic treatment, subjects are eligible if they have completed antibiotic therapy 2 weeks prior to study enrollment. 9. History of suspected or confirmed PML 10. Clinically significant cardiovascular disease including the following: 1. Myocardial infarction within 6 months before screening. 2. Unstable angina within 3 months before screening. 3. New York Heart Association class III or IV congestive heart failure 4. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes). 5. QT interval corrected with Fridericia's formula (QTcF) \> 480 milliseconds based on Fridericia's formula. 6. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place. 7. Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 105 mmHg at screening. 11. Patients with stroke or CNS hemorrhage within 6 months. 12. Pregnant or breastfeeding. 14\. Major surgical procedure within 28 days of first dose of study drug. If a subject had surgery, they must have recovered adequately from any toxicity or complications before the first dose of study drug. 15\. Has difficulty with or is unable to swallow oral medication or has significant gastrointestinal disease that would limit absorption of oral medication. 16\. Subject is known to be positive for human immunodeficiency virus (HIV). 17. Active hepatitis C, as confirmed by being positive for Hep C RNA by PCR. 18. Active hepatitis B infection documented by a positive PCR for Hep B DNA. If hepatitis B serology is positive for hepatitis B core antibody, but Hep B DNA PCR is negative, patient is eligible to enroll. 19\. Subject requires: 1. Strong and moderate CYP3A inhibitors within 7 days prior to the initiation of study treatment. 2. Strong and moderate CYP3A inducers within 7 days prior to the initiation of study treatment. 3. Steroid therapy for anti-neoplastic intent with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids within 7 days prior to the first dose of study drug administration. 4. Consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug and throughout venetoclax administration. 20\. Known hypersensitivity reactions (e.g., anaphylaxis) to obinutuzumab or any of the excipients, including serum sickness with prior obinutuzumab use. 21\. Vaccination with live vaccine ≤28 days prior to start of treatment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Weill Cornell Medicine/NewYork-Presberteryian Hospital
New York, New York, 10021, United States
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