REtreatment With VEnetoclax and Acalabrutinib After Venetoclax Limited Duration (REVEAL)

Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Study ID
NCT04523428
Phase
PHASE2
Status
Recruiting
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Conditions

  • CLL/SLL

Eligibility Criteria

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

Interventions

  • Venetoclax/Acalabrutinib — DRUG
    All patients will receive a lead-in with 2 cycles of acalabrutinib 100 mg bid. Hereafter patients will continue with ramp-up of venetoclax followed by daily 400 mg venetoclax in combination with acalabrutinib for 24 cycles. Patients will be treated until they have received a total of 26 cycles or until progression, whichever comes first.

Study Details

Fixed-duration regimens containing combinations of venetoclax with CD20 targeting agents are expected to soon become standard practice in first-line patients with chronic lymfocytic leukemia (CLL). The advantage of a fixed duration venetoclax combination as part of first-line treatment is the potential to retreat with venetoclax in patients who develop relapsed disease after a treatment free period. However, efficacy of venetoclax retreatment following a fixed duration venetoclax combination is still hypothetical as clinical data are lacking. Thus, there is an urgent need for data proving efficacy of venetoclax combinations following venetoclax treatment cessation. Testing of a novel venetoclax-containing regimen for relapsed CLL without the repeat of anti-CD20 monoclonal antibody (mAb) is a rational approach.

Key Dates

Start date
Dec 23, 2020
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2032

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax/Acalabrutinib
    All patients will receive a lead-in with 2 cycles of acalabrutinib 100 mg bid. Hereafter patients will continue with ramp-up of venetoclax followed by daily 400 mg venetoclax in combination with acalabrutinib for 24 cycles. Patients will be treated until they have received a total of 26 cycles or until progression, whichever comes first.

Primary Outcome Measure

uMRD in BM by flow cytometry after 26 cycles (2 acalabrutinib and 24 AV). [ Time Frame: 26 months ]

Central Contacts

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