NL-OMON52681Not yet recruitingPhase 2
Short-term combined acalabrutinib and venetoclax treatment of newly diagnosed patients with CLL at high risk of infection and/or early treatment, who do not fulfil IWCLL treatment criteria for treatment. A randomized study with extensive immune phenotyping. - PreVent-ACa
Rigshospitalet/Copenhagen University hospital0 sites20 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1. CLL diagnosed according to IWCLL criteria within one year prior to
- •randomization
- •2. High risk of infection and/or progressive treatment within 2 years according
- •to CLL-TIM
- •3. IWCLL treatment indication not fulfilled
- •4. Life expectancy > 2 years
- •5. Age at least 18 years
- •6. Ability and willingness to provide written informed consent and adhere to
- •study procedures and treatment
- •7. Adequate bone marrow function as indicated by platelets above 100 x 10E9,
- •hemoglobin above 10 g/dL and neutrophils above 1 x 10E9
- •8. Creatinine clearance above 30 mL/min directly measured with 24hr urine
- •collection or calculated according to the modified formula of Cockcroft and
- •9. Adequate liver function as indicated by a total bilirubin<= 2 x, AST or ALT <=
- •2.5 x the institutional ULN value, unless directly attributable to the
- •patient*s CLL or to Gilbert*s Syndrome.
- •10. Negative serological testing for hepatitis B (HBsAg negative and anti-HBc
- •negative; patients positive for anti-HBc may be included if PCR for HBV DNA is
- •negative and HBV-DNA PCR is performed every month until 12 months after last
- •treatment cycle), negative testing for hepatitis C RNA within 6 weeks prior to
- •registration.
- •11. Eastern Cooperative Oncology Group Performance Status (ECOG) performance
- •status 0-2.
- •12. Woman of childbearing potential (WOCBP) who are sexually active must use
- •highly effective methods of contraception during treatment and for 30 days
- •after the last dose of investigational drugs.
- •13. Willing and able to participate in all required evaluations and procedures
- •in this study protocol including swallowing capsules without difficulty.
- •14. Ability to understand the purpose and risks of the study and provide signed
- •and dated informed consent and authorization to use protected health
- •information.
Exclusion Criteria
- •1. Prior CLL treatment (including monoclonal antibodies, chemotherapy, small
- •molecules, including CD20 antibodies, BTK inhibitors and bcl-2 inhibitors for
- •any indication)
- •2. Transformation of CLL (Richter*s transformation)
- •3. Previous autoimmune disease as AIHA (autoimmune hemolytic anemia) or ITP
- •(idiopathic thrombocytopenic purpura) treated with immune suppression or
- •uncontrolled AIHA or ITP
- •4. History of progressive multifocal leukoencephalopathy
- •5. HIV infection (a negative test required)
- •6. Known active infection
- •7. Malignancies other than CLL requiring systemic therapies (except
- •anti-hormonal therapies) or considered to impact survival
- •8. Requirement of therapy with strong CYP3A4 and CYP3A5 inhibitors/inducers or
- •anticoagulant therapy with vitamin K antagonists
- •9. History of bleeding disorders or current platelet inhibitors or
- •anticoagulant therapy
- •10. History of clinically significant cardiovascular disease such as
- •arrhythmias, congestive heart failure, or myocardial infarction within 6 months
- •of screening, or any Class 3 or 4 cardiac disease as defined by the New York
- •Heart Association
- •Functional Classification, or corrected QT interval (QTc) > 480 msec at
- •11. History of stroke or intracranial hemorrhage within 6 months prior to
- •registration.
- •12. Use of investigational agents which might interfere with the study drug
- •within 28 days prior to registration.
- •13. Vaccination with live vaccines within 28 days prior to registration.
- •14. Major surgery less than 30 days before start of treatment. Note: If a
- •subject had major surgery, they must have recovered adequately from any
- •toxicity and/or complications from the intervention before the first dose of
- •study drug.
- •15. Known hypersensitivity to any active substance or to any of the excipients
- •of one of the drugs used in the trial.
- •16. Pregnant women and nursing mothers (a negative pregnancy test is required
- •for all women of childbearing potential within 7 days before start of
- •treatment; further pregnancy testing will be performed regularly).
- •17. Fertile men or women of childbearing potential unless: surgically sterile
- •or >= 2 years after the onset of menopause or willing to use two methods of
- •reliable contraception including one highly effective contraceptive method
- •(Pearl Index <1) and one additional effective (barrier) method during study
- •treatment and for 30 days after the end of study treatment.
- •18. Legal incapacity.
- •19. Persons who are in dependence to the sponsor or an investigator
- •20. Persons not considered fit for the trial by the investigator
- •21. Malabsorption syndrome, disease significantly affecting gastrointestinal
- •function, or resection of the stomach or small bowel that is likely to affect
- •absorption, symptomatic inflammatory bowel disease, partial or complete bowel
- •obstruction, or gastric restrictions and bariatric surgery, such as gastric
- •22. Prothrombin time/INR or aPTT (in the absence of Lupus anticoagulant) > 2x
- •23. Requires treatment with proton pump inhibitors (e.g., omeprazole,
- •esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole).
- +2 more not shown
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