NCT03422393Active, not recruitingPhase 1
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 · Last updated 5 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 30 Jan 2018
- Start date
- 1 May 2018
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- Michael Choi
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT03422393
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From 1 May 2018 to the primary completion date, 31 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of major surgery within 4 weeks prior to first dose on this study.
- Requires treatment with a strong cytochrome P(CYP)450 3A inhibitor.
Other illness
- History of Richter's or prolymphocytic transformation.
- Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP)
- 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.
- Current infection requiring parenteral antibiotics.
- Active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification.
Lab values
- Patients who require immediate cytoreduction due to high risk of tumor lysis syndrome (ie, absolute lymphocyte count greater than 100k/uL).
Other
- Known CNS lymphoma or leukemia
- Primary ibrutinib resistance
- Requires anticoagulation with warfarin or other Vitamin K antagonists.
- Pregnant or breast-feeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UC San Diego Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.