Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment

Sponsor
Rigshospitalet, Denmark
Study ID
NCT03868722
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    Acalabrutinib 100 mg BID from cycle 1 day 1 for 3 cycles of 28 days.
  • Venetoclax — DRUG
    Venetoclax, ramp up during the first five weeks starting cycle 1 day 1, 7 days treatment on each dose level (20-50-100-200-400 mg), thereafter 400 mg once daily for a total of 3 cycles of 28 days.

Study Details

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.

Key Dates

Start date
Oct 11, 2019
Status verified
Dec 2023
Primary completion
Jul 31, 2029
Completion
Jul 31, 2030

Study Design

Enrollment
212 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Treatment arm
    Treatment with Acalabrutinib and Venetoclax is initiated within 14 days after randomization.
  • No Intervention: Observation arm
    Observation period is initiated within 14 days after randomization.

Primary Outcome Measure

Grade 3-Infection-free survival [ Time Frame: 12 weeks after finishing treatment ]

Central Contacts

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