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

ConditionCLL
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: Treatment armExperimental treatment 2 interventions
Group B: Observation armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Grade 3-Infection-free survival

Grade 3-Infection-free survival in the treatment arm compared to the observation arm

Time frame
12 weeks after finishing treatment
2

Event-free survival

Event-free survival, event being either grade ≥3 infection or CLL treatment

Time frame
2 years after enrollment

Secondary outcomes

1

Event-free survival

Event-free survival, event being either grade ≥3 infection or CLL treatment

Time frame
12 weeks after treatment initiation,1 year and 2 years after enrollment
2

Overall survival

Overall survival

Time frame
Assessed at 12 weeks, 1 year and 2 years from treatment/observation initiation
3

Treatment free survival

Treatment free survival

Time frame
Assessed at 12 weeks, 1 year and 2 years from treatment/observation initiation
4

Rate of infections

Rate of infections

Time frame
assessed at 12 weeks, 1 year and 2 years from treatment/observation initiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborator

Karolinska Institutet

Collaborator

Source ClinicalTrials.gov
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