Clinical trial · Interventional
Venetoclax With High-dose Ibrutinib for CLL Progressing on Single Agent Ibrutinib
A Phase 1 Clinical Trial to Evaluate Venetoclax With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to investigate whether the combination of venetoclax and ibrutinib (administered up to 840 mg per day) might be useful for the treatment of CLL or SLL that is not responding or no longer responding to treatment with ibrutinib alone. The study will evaluate whether this regimen can reduce the amount of cancerous cells in your body. If you agree, you will receive ibrutinib at a dose of up to 840 mg a day by mouth, as well as venetoclax. Although both of these agents are approved by the FDA for the treatment of CLL or SLL, the combination and the dosing schedule of ibrutinib are considered experimental.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- venetoclax with high-dose ibrutinib
- description
- venetoclax with high-dose ibrutinib for the treatment of patients with chronic lymphocytic leukemia with progressive disease on single agent ibrutinib.
- interventionNames
- Drug: Venetoclax
- Drug: Ibrutinib
Primary outcomes (1)
- measure
- Maximum tolerated dose or biologically active dose.
- timeFrame
- 1 year or more
- description
- Maximum tolerated dose or biologically active dose.
Secondary outcomes (4)
- measure
- Treatment-emergent adverse events
- timeFrame
- 2 years or more
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical and phenotypic verification of B cell CLL or SLL and measurable disease. * Prior therapy: Patients must have been receiving single agent ibrutinib therapy at the time of disease progression. Patient may have received other therapy in combination with ibrutinib earlier in their treatment course. * Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. * Adequate hematologic, hepatic and renal function Exclusion Criteria: * Known CNS lymphoma or leukemia * History of Richter's or prolymphocytic transformation. * Primary ibrutinib resistance * Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP) * History of major surgery within 4 weeks prior to first dose on this study. * History of prior malignancy, with the exception of adequately treated non-melanoma skin cancer, malignancies treated with curative intent and with no evidence of active disease for more than 3 years, or adequately treated cervical carcinoma in situ without current evidence of disease. * Active clinically significant cardiovascular disease or history of myocardial infarction within 6 months of first dose. * Active hepatitis B or C infection. * Known history of infection with human immunodeficiency virus (HIV). * Unable to swallow capsules or disease significantly affecting gastrointestinal function. * History of stroke or intracranial hemorrhage within 6 months of first dose. * Requires anticoagulation with warfarin or other Vitamin K antagonists. * Requires treatment with a strong cytochrome P(CYP)450 3A inhibitor. * Pregnant or breast-feeding women * Current infection requiring parenteral antibiotics. * Active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification. * Patients who require immediate cytoreduction due to high risk of tumor lysis syndrome (ie, absolute lymphocyte count greater than 100k/uL).
References
Publications (0)
Data not yet available