Venetoclax and Decitabine in Treating Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome

Summary

This phase II trial studies how well venetoclax and decitabine work in treating participants with acute myeloid leukemia that has come back or does not respond to treatment, or with high-risk myelodysplastic syndrome that has come back. Drugs used in chemotherapy, such as venetoclax and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Timeline

Start

2018-01-18

Primary completion

2026-03-05

Completion

2026-03-05

Outcome

Outcome not reported

Stopped: “\<75% participation”

Publications

• Venugopal S, Maiti A, DiNardo CD, Qiao W, Ning J, Loghavi S, Daver NG, Kadia TM, Rausch CR, Alvarado Y, Ohanian M, Sasaki K, Short NJ, Takahashi K, Yilmaz M, Ravandi F, Kantarjian HM, Konopleva MY. Prognostic impact of conventional cytogenetics in acute myeloid leukemia treated with venetoclax and decitabine. Leuk Lymphoma. 2021 Dec;62(14):3501-3505. doi: 10.1080/10428194.2021.1973675. Epub 2021 Sep 3. No abstract available.
• Kim K, Maiti A, Loghavi S, Pourebrahim R, Kadia TM, Rausch CR, Furudate K, Daver NG, Alvarado Y, Ohanian M, Sasaki K, Short NJ, Takahashi K, Yilmaz M, Tang G, Ravandi F, Kantarjian HM, DiNardo CD, Konopleva MY. Outcomes of TP53-mutant acute myeloid leukemia with decitabine and venetoclax. Cancer. 2021 Oct 15;127(20):3772-3781. doi: 10.1002/cncr.33689. Epub 2021 Jul 13.
• Maiti A, DiNardo CD, Wang SA, Jorgensen J, Kadia TM, Daver NG, Short NJ, Yilmaz M, Pemmaraju N, Borthakur G, Bose P, Issa GC, Ferrajoli A, Jabbour EJ, Jain N, Garcia-Manero G, Ohanian M, Takahashi K, Montalban-Bravo G, Masarova L, Burger JA, Thompson PA, Verstovsek S, Sasaki K, Andreeff M, Rausch CR, Montalbano KS, Pierce S, Qiao W, Ning J, Kantarjian HM, Konopleva MY, Ravandi F. Prognostic value of measurable residual disease after venetoclax and decitabine in acute myeloid leukemia. Blood Adv. 2021 Apr 13;5(7):1876-1883. doi: 10.1182/bloodadvances.2020003717.
• Venugopal S, Maiti A, DiNardo CD, Loghavi S, Daver NG, Kadia TM, Rausch CR, Alvarado Y, Ohanian M, Sasaki K, Short NJ, Takahashi K, Yilmaz M, Ravandi F, Kantarjian HM, Konopleva MY. Decitabine and venetoclax for IDH1/2-mutated acute myeloid leukemia. Am J Hematol. 2021 May 1;96(5):E154-E157. doi: 10.1002/ajh.26122. Epub 2021 Feb 19. No abstract available.
• Laribi K, Baugier de Materre A, Sobh M, Cerroni L, Valentini CG, Aoki T, Suzuki R, Takeuchi K, Frankel AE, Cota C, Ghez D, Le Calloch R, Pagano L, Petrella T. Blastic plasmacytoid dendritic cell neoplasms: results of an international survey on 398 adult patients. Blood Adv. 2020 Oct 13;4(19):4838-4848. doi: 10.1182/bloodadvances.2020002474.
• DiNardo CD, Maiti A, Rausch CR, Pemmaraju N, Naqvi K, Daver NG, Kadia TM, Borthakur G, Ohanian M, Alvarado Y, Issa GC, Montalban-Bravo G, Short NJ, Yilmaz M, Bose P, Jabbour EJ, Takahashi K, Burger JA, Garcia-Manero G, Jain N, Kornblau SM, Thompson PA, Estrov Z, Masarova L, Sasaki K, Verstovsek S, Ferrajoli A, Weirda WG, Wang SA, Konoplev S, Chen Z, Pierce SA, Ning J, Qiao W, Ravandi F, Andreeff M, Welch JS, Kantarjian HM, Konopleva MY. 10-day decitabine with venetoclax for newly diagnosed intensive chemotherapy ineligible, and relapsed or refractory acute myeloid leukaemia: a single-centre, phase 2 trial. Lancet Haematol. 2020 Oct;7(10):e724-e736. doi: 10.1016/S2352-3026(20)30210-6. Epub 2020 Sep 5.

Drugs

Indications