Actively Recruiting
Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment
Led by Rigshospitalet, Denmark · Updated on 2023-12-04
212
Participants Needed
7
Research Sites
563 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
S
Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Serious infections due to CLL are responsible for one third of all deaths among CLL patients. PreVent-ACaLL study will investigate whether a combination of two known types of cancer drugs can reduce the risk of infection and thus mortality when given preventively to newly diagnosed CLL patients. A newly developed register-based computer model can predict which patients are at high risk in order to develop infections as a result of their CLL. A preventive treatment might be initiated before patients need chemotherapy. In this way, the cancer disease might be "reset" so that the immune system, which is inhibited by CLL, is restored and the risk of fatal infections is minimized.
CONDITIONS
Official Title
Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with CLL according to IWCLL criteria within one year before randomization
- High risk of infection or need for progressive treatment within 2 years based on CLL-TIM model
- Does not meet IWCLL treatment criteria
- Life expectancy greater than 2 years
- Age 18 years or older
- Able and willing to give written informed consent and follow study procedures
- Adequate bone marrow function with platelets above 100 x 10^9/L, hemoglobin above 10 g/dL, and neutrophils above 1 x 10^9/L
- Creatinine clearance above 30 mL/min measured by 24-hour urine or Cockcroft-Gault formula
- Adequate liver function: total bilirubin ≤ 2 times, AST/ALT ≤ 2.5 times institutional upper limit unless due to CLL or Gilbert's Syndrome
- Negative hepatitis B serology (HBsAg and anti-HBc negative; if anti-HBc positive, negative HBV-DNA PCR monthly for 12 months after treatment)
- Negative hepatitis C RNA test within 6 weeks before registration
- ECOG performance status 0 to 2
- Women of childbearing potential must use highly effective contraception during treatment and for 2 days after last dose
- Willing and able to participate in all study evaluations including swallowing capsules
- Understands study purpose and risks and can provide signed informed consent
You will not qualify if you...
- Prior treatment for CLL including monoclonal antibodies, chemotherapy, or small molecules
- Transformation of CLL (Richter's transformation)
- Previous or uncontrolled autoimmune diseases like AIHA or ITP treated with immune suppression
- History of progressive multifocal leukoencephalopathy (PML)
- Active or uncontrolled infection
- Other cancers requiring systemic therapy or affecting survival (except anti-hormonal therapy)
- Need for strong CYP3A4/5 inhibitors or anticoagulants with vitamin K antagonists
- History of bleeding disorders or current use of platelet inhibitors or anticoagulants
- Significant cardiovascular disease or recent heart events within 6 months
- History of stroke or brain hemorrhage within past 6 months
- Use of investigational agents in past 28 days
- Vaccination with live vaccines within 28 days
- Major surgery within 30 days before treatment
- Known allergy to study drugs or their ingredients
- Pregnant or breastfeeding women; negative pregnancy test required for women of childbearing potential
- Fertile men or women unless surgically sterile, postmenopausal ≥ 2 years, or using two reliable contraception methods during and 18 months after study
- Legal incapacity or dependence on sponsor/investigator
- Medical conditions affecting gastrointestinal absorption or recent ulcers
- Use of strong CYP3A4 inhibitors/inducers or proton pump inhibitors (unless switched to alternatives)
- Major surgery within 7 days before first dose
- Not considered fit for trial by investigator
- Elevated clotting times (PT/INR or aPTT > 2x upper limit)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
2
Herlev og Gentofte Hospital
Herlev, Denmark, 2730
Actively Recruiting
3
Sjællands Universitetshospital Roskilde
Roskilde, Denmark, 4000
Actively Recruiting
4
Albert Schweitzer Hospital
Dordrecht, Netherlands, 3318
Actively Recruiting
5
Ikazia Hospital (Ikazia Ziekenhuis)
Rotterdam, Netherlands, 3083
Actively Recruiting
6
Örebro University Hospital
Örebro, Sweden, 701 85
Actively Recruiting
7
Karolinska University Hospital
Stockholm, Sweden, 171 76
Actively Recruiting
Research Team
C
Carsten U Niemann, MD, PhD
CONTACT
B
Bitten Aagaard, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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