REtreatment With VEnetoclax and Acalabrutinib After Venetoclax Limited Duration (REVEAL)
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
| Condition(s) | CLL/SLL |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: * Documented CLL or SLL requiring treatment according to IWCLL criteria (appendix A) after at least (clinical) partial response as best response after the following initial study treatment: venetoclax-rituximab in HOVON 140/GAIA or venetoclax-obinutuzumab in HOVON 139/GIVE or HOVON 140/GAIA; * WHO/ECOG performance status 0-3 (appendix C), stage 3 only if attributable to CLL * Age at least 18 years; * Adequate BM function defined as: * Hemoglobin \>5 mmol/l or Hb \> 8 g/dL * Absolute neutrophil count (ANC) \>0.75 x 109/L (750/μL), unless directly attributable to CLL infiltration of the BM, proven by BM biopsy * Platelet count \>30 x 109/L (30,000/μL) without transfusion and irrespective whether it is attributable to CLL infiltration in the BM; * Estimated Glomerular Filt |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Stichting Hemato-Oncologie voor Volwassenen Nederland |
| Locations | Brussels, Belgium; Leuven, Belgium; Aarhus, Denmark; 's-Hertogenbosch, Netherlands; Amsterdam, Netherlands; Arnhem, Netherlands (+12 more sites) |
| Start date | 2020-12-23 |
| NCT ID | NCT04523428 |
| Official listing | https://clinicaltrials.gov/study/NCT04523428 |