RecruitingPhase 2NCT04523428

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

A Prospective, Multicenter, Phase-II Trial of Venetoclax Plus Acalabrutinib in Patients Who Have Relapsed After First Line Venetoclax + Anti-CD20 mAb Treatment for Chronic Lymphocytic Leukemia (CLL or SLL)


Sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Enrollment

60 participants

Start Date

Dec 23, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether patients with chronic lymphocytic leukemia (CLL) who previously completed a time-limited course of venetoclax (a targeted cancer drug) and then relapsed can benefit from retreatment with venetoclax, this time combined with acalabrutinib. **You may be eligible if...** - You have CLL or small lymphocytic lymphoma (SLL) that requires treatment again - You previously received venetoclax as part of a specific clinical study (HOVON 139 or HOVON 140) and had at least a partial response - Your disease has now relapsed and meets standard criteria for retreatment - You are in reasonably good health (ECOG 0-3) **You may NOT be eligible if...** - You have certain genetic mutations that may make treatment less effective - You have significant organ dysfunction - You developed serious complications from prior venetoclax treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax/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.


Locations(18)

BE-Bruxelles-STLUC

Brussels, Belgium

BE-Leuven-UZLEUVEN

Leuven, Belgium

DK-Aarhus N-AUH

Aarhus, Denmark

NL-Den Bosch-JBZ

's-Hertogenbosch, Netherlands

NL-Amsterdam-AMC

Amsterdam, Netherlands

NL-Arnhem-RIJNSTATE

Arnhem, Netherlands

NL-Breda-AMPHIA

Breda, Netherlands

NL-Delft-RDGG

Delft, Netherlands

NL-Dordrecht-ASZ

Dordrecht, Netherlands

NL-Ede-ZGV

Ede, Netherlands

NL-Eindhoven-MAXIMAMC

Eindhoven, Netherlands

NL-Groningen-UMCG

Groningen, Netherlands

NL-Leeuwarden-MCL

Leeuwarden, Netherlands

NL-Maastricht-MUMC

Maastricht, Netherlands

NL-Nieuwegein-ANTONIUS

Nieuwegein, Netherlands

NL-Rotterdam-IKAZIA

Rotterdam, Netherlands

NL-Rotterdam-MAASSTADZIEKENHUIS

Rotterdam, Netherlands

NL-Utrecht-UMCUTRECHT

Utrecht, Netherlands

View Full Details on ClinicalTrials.gov

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NCT04523428


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