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HOVON 159 CLL: 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)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505449-18-00
Acronym
HO159
Enrollment
60
Registered
2024-11-11
Start date
2020-07-23
Completion date
Unknown
Last updated
2025-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lymphocytic leukemia, Patients with relapsed CLL

Brief summary

uMRD in bone marrow (BM) by flow cytometry after 26 cycles

Detailed description

Depth of MRD measured in BM after cycle 13 and 26, Depth of MRD measured in PB after cycle 8, 10, 13, 16, 19, 22, 26 and every 3-6 months thereafter, Best overall response rate (ORR) defined as the proportion of subjects with a complete response (CR), complete response with incomplete marrow recovery (CRi), or partial response (PR) according to IWCLL 2018 criteria, Progression free survival (PFS), defined as time from registration to the first occurrence of disease progression or death from any cause (whichever occurs first)., Event free survival (EFS), defined as time from registration to date start of first CLL treatment off protocol, progression or death, whichever comes first, Overall survival (OS), defined as the time from registration to death from any cause, Treatment free interval (TFI), defined as date of last protocol treatment to start date of first CLL treatment off protocol, or death from any cause whichever comes first, Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0, Exploratory: Depth of MRD by different techniques (flow cytometry, circulating tumor DNA (ctDNA), next-generation sequencing), Exploratory: TruCulture and flow cytometry for immune subsets and function, Exploratory: Grading of hematological toxicity according to IWCLL20, Exloratory: Disease-related symptoms and health-related quality of life (HRQoL) measured by following questionnaires: EORTC QLQ-C30, EORTC QLQCLL17 and PRO-CTCAE

Interventions

DRUGVenetoclax
DRUGAcalabrutinib

Sponsors

Haemato Oncology Foundation For Adults Netherlands
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
uMRD in bone marrow (BM) by flow cytometry after 26 cycles

Secondary

MeasureTime frame
Depth of MRD measured in BM after cycle 13 and 26, Depth of MRD measured in PB after cycle 8, 10, 13, 16, 19, 22, 26 and every 3-6 months thereafter, Best overall response rate (ORR) defined as the proportion of subjects with a complete response (CR), complete response with incomplete marrow recovery (CRi), or partial response (PR) according to IWCLL 2018 criteria, Progression free survival (PFS), defined as time from registration to the first occurrence of disease progression or death from any cause (whichever occurs first)., Event free survival (EFS), defined as time from registration to date start of first CLL treatment off protocol, progression or death, whichever comes first, Overall survival (OS), defined as the time from registration to death from any cause, Treatment free interval (TFI), defined as date of last protocol treatment to start date of first CLL treatment off protocol, or death from any cause whichever comes first, Incidence and severity of AEs, with severity determi

Countries

Belgium, Denmark, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026