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New treatment option for CLL
Official title Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment
ClinicalTrials.gov ID: NCT03868722
What this study is testing
What is Acalabrutinib?
Acalabrutinib is an investigational medicine, being studied as a potential treatment for cll.
Also referred to as Calquence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Many patients with CLL have a weakened immune system due to their disease. It increases their risk of developing serious, treatment-requiring infections such as blood poisoning or pneumonia, which in the worst case may end with fatal outcomes.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- CLL diagnosed according to IWCLL criteria within one year prior to randomization
- High risk of infection and/or progressive treatment within 2 years according to CLL-TIM
- IWCLL treatment indication not fulfilled
- Life expectancy \> 2 years
- Age at least 18 years
You likely can't join if
- Prior CLL treatment (including monoclonal antibodies, chemotherapy, small molecules)
- Transformation of CLL (Richter's transformation)
- Previous autoimmune disease as AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura) treated with immune suppression or...
- History of PML
- Uncontrolled or active infection
- Malignancies other than CLL requiring systemic therapies (except anti-hormonal therapies) or considered to impact survival
See the full eligibility criteria
- CLL diagnosed according to IWCLL criteria within one year prior to randomization
- High risk of infection and/or progressive treatment within 2 years according to CLL-TIM
- IWCLL treatment indication not fulfilled
- Life expectancy \> 2 years
- Age at least 18 years
- Ability and willingness to provide written informed consent and adhere to study procedures and treatment
- Adequate bone marrow function as indicated by platelets above 100 x 10E9, hemoglobin above 10 g/dL and neutrophils above 1 x 10E9
- Creatinine clearance above 30 mL/min directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault
- Adequate liver function as indicated by a total bilirubin≤ 2 x, AST/ALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient's CLL or to Gilbert's Syndrome.
- 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...
- Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0-2.
- Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for 2 days after the last dose of investigational drugs.
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
- Prior CLL treatment (including monoclonal antibodies, chemotherapy, small molecules)
- Transformation of CLL (Richter's transformation)
- Previous autoimmune disease as AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura) treated with immune suppression or uncontrolled AIHA or ITP
- History of PML
- Uncontrolled or active infection
- Malignancies other than CLL requiring systemic therapies (except anti-hormonal therapies) or considered to impact survival
- Requirement of therapy with strong CYP3A4 and CYP3A5 inhibitors/inducers or anticoagulant therapy with vitamin K antagonists
- History of bleeding disorders or current platelet inhibitors or anticoagulant therapy
- 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...
- History of stroke or intracranial hemorrhage within 6 months prior to registration.
- Use of investigational agents which might interfere with the study drug within 28 days prior to registration.
- Vaccination with live vaccines 28 days prior to registration.
- Major surgery less than 30 days before start of treatment.
- Known hypersensitivity to any active substance or to any of the excipients of one of the drugs used in the trial.
- 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).
- 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...
- Legal incapacity.
- Persons who are in dependence to the sponsor or an investigator
- Persons not considered fit for the trial by the investigator
- 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...
- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer.
- Prothrombin time/INR or aPTT (in the absence of Lupus anticoagulant) \> 2x ULN.
- Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). people receiving proton pump inhibitors who switch to H2-receptor antagonists...
- Major surgical procedure within 7 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first...
- Breastfeeding or pregnant.
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
- Herlev, Denmark
- Roskilde, Denmark
- Dordrecht, Netherlands
- Rotterdam, Netherlands
- Örebro, Sweden
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark; Herlev, Denmark; Roskilde, Denmark; Dordrecht, Netherlands; Rotterdam, Netherlands; Örebro, Sweden and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.