Chemotherapy and Venetoclax in Elderly Acute Myeloid Leukemia Trial (CAVEAT): A Phase Ib Dose-Escalation Study of Venetoclax Combined With Modified Intensive Chemotherapy.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Chong Chyn ChuaAndrew H Wei

Abstract

The B-cell lymphoma 2 (BCL-2) inhibitor venetoclax has an emerging role in acute myeloid leukemia (AML), with promising response rates in combination with hypomethylating agents or low-dose cytarabine in older patients. The tolerability and efficacy of venetoclax in combination with intensive chemotherapy in AML is unknown. Patients with AML who were ≥ 65 years (≥ 60 years if monosomal karyotype) and fit for intensive chemotherapy were allocated to venetoclax dose-escalation cohorts (range, 50-600 mg). Venetoclax was administered orally for 14 days each cycle. During induction, a 7-day prephase/dose ramp-up (days -6 to 0) was followed by an additional 7 days of venetoclax combined with infusional cytarabine 100 mg/m2 on days 1-5 and idarubicin 12 mg/m2 intravenously on days 2-3 (ie, 5 + 2). Consolidation (4 cycles) included 14 days of venetoclax (days -6 to 7) combined with cytarabine (days 1-2) and idarubicin (day 1). Maintenance venetoclax was permitted (7 cycles). The primary objective was to assess the optimal dose schedule of venetoclax with 5 + 2. Fifty-one patients with a median age of 72 years (range, 63-80 years) were included. The maximum tolerated dose was not reached with venetoclax 600 mg/day. The main grade ≥ 3 no...Continue Reading

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Citations

Jul 31, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Gert Ossenkoppele, Paresh Vyas
Aug 25, 2020·American Journal of Hematology·Elihu H Estey
Sep 22, 2020·Minerva medica·Maria Paola MartelliClaudio Cerchione
Nov 11, 2020·Blood·Brunangelo FaliniMaria Paola Martelli
Dec 15, 2020·Journal of Hematology & Oncology·Arnold BolomskyJo Caers
Feb 26, 2021·Therapeutic Advances in Hematology·Ibrahim AldossAnthony S Stein
Mar 21, 2021·Current Treatment Options in Oncology·Kapil Saxena, Marina Konopleva
Mar 25, 2021·Journal of Hematology & Oncology·Hongtao Liu
Apr 22, 2021·Leukemia·Brunangelo FaliniMaria Paola Martelli
Mar 30, 2021·Journal of Internal Medicine·V Lj Lazarevic
May 20, 2021·Nature Reviews. Clinical Oncology·Hartmut DöhnerBob Löwenberg
May 28, 2021·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Courtney D DiNardoHagop M Kantarjian
Jun 5, 2021·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Andrew H WeiHagop M Kantarjian
Jun 29, 2021·Clinical Lymphoma, Myeloma & Leukemia·Hagop M KantarjianAndrew H Wei
Aug 28, 2021·Journal of Personalized Medicine·Ida Sofie GrønningsæterKimberley Joanne Hatfield
Jul 29, 2021·Blood·Andrew W RobertsDavid C S Huang
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Oct 31, 2021·American Journal of Hematology·Koji SasakiHagop Kantarjian
Nov 19, 2021·Expert Review of Clinical Pharmacology·Maria Siddiqui, Marina Konopleva

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