Phase 1 study of the Aurora kinase A inhibitor alisertib (MLN8237) combined with the histone deacetylase inhibitor vorinostat in lymphoid malignancies

Siddiqi, Tanya; Frankel, Paul; Beumer, Jan H.; Kiesel, Brian F.; Christner, Susan; Ruel, Chris; Song, Joo Y.; Chen, Robert; Kelly, Kevin R.; Ailawadhi, Sikander; Kaesberg, Paul; Popplewell, Leslie; Puverel, Sandrine; Piekarz, Richard; Forman, Stephen J.; Newman, Edward M.

doi:10.1080/10428194.2019.1672052

Cited by 30Lymphoma Diagnosis and TreatmentAcute Lymphoblastic Leukemia researchAcute Myeloid Leukemia Research

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Phase 1 study of the Aurora kinase A inhibitor alisertib (MLN8237) combined with the histone deacetylase inhibitor vorinostat in lymphoid malignancies

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Siddiqi, Tanya, Frankel, Paul, Beumer, Jan H., Kiesel, Brian F., Christner, Susan, Ruel, Chris, Song, Joo Y., Chen, Robert, Kelly, Kevin R., Ailawadhi, Sikander, Kaesberg, Paul, Popplewell, Leslie, Puverel, Sandrine, Piekarz, Richard, Forman, Stephen J., Newman, Edward M.·2020·Leukemia & Lymphoma

DOI 10.1080/10428194.2019.1672052PMC PMC6982547

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Abstract

Alisertib, an Aurora kinase A inhibitor, was evaluated in a Phase 1 study in combination with the histone deacetylase inhibitor vorinostat, in patients with relapsed/refractory lymphoid malignancies (N = 34; NCT01567709). Patients received alisertib plus vorinostat in 21-day treatment cycles with escalating doses of alisertib following a continuous or an intermittent schedule. All dose-limiting toxicities (DLTs) were hematologic and there were no study-related deaths. The recommended phase 2 dose (RP2D) of the combination was 20 mg bid of alisertib and 200 mg bid of vorinostat on the intermittent schedule. A 13-patient expansion cohort was treated for a total of 18 patients at the RP2D. There were no DLTs at the RP2D, and toxicities were mainly hematologic. Two patients with DLBCL achieved a durable complete response, and two patients with HL achieved partial response. Alisertib plus vorinostat showed encouraging clinical activity with a manageable safety profile in heavily pretreated patients with advanced disease.

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Results of a recent clinical trial (NCT04467931) show vorinostat is a promising candidate drug for T cell acute lymphoblastic leukemia.
“The results of a recent clinical trial (ClinicalTrials.gov Identifier: NCT04467931) show vorinostat is a promising candidate drug for T cell acute lymphoblastic leukemia73.”
From ASGARD is a single-cell guided pipeline to aid repurposing of drugs (2023) · cites this paper as [73]

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Authors: Siddiqi, T., Frankel, P., Beumer, J. H., Kiesel, B. F., Christner, S., Ruel, C., Song, J. Y., Chen, R., Kelly, K. R., Ailawadhi, S., Kaesberg, P., Popplewell, L., Puverel, S., Piekarz, R., Forman, S. J., & Newman, E. M.
Affiliations: City Of Hope National Medical Center (US)
University of Pittsburgh (US)
UPMC Hillman Cancer Center (US)
Department of Information Sciences, City of Hope National Medical Center, Duarte, CA, USA;
University of Southern California (US)
Mayo Clinic in Florida (US)
University of California Davis Medical Center (US)
National Institutes of Health (US)
Corresponding author: Siddiqi, Tanya
ORCID: Siddiqi, Tanya
Frankel, Paul
Beumer, Jan H.
Kiesel, Brian F.
Christner, Susan
Song, Joo Y.
Chen, Robert
Kelly, Kevin R.
Ailawadhi, Sikander
Popplewell, Leslie
Puverel, Sandrine
Piekarz, Richard
Forman, Stephen J.
Newman, Edward M.
Venue: Leukemia & Lymphoma
Publisher: Informa UK Limited
Published: 2019-10-16
Volume: 61
Issue: 2
Pages: 309-317
ISSN: 1026-8022 (ISSN-L)
1042-8194
1029-2403
DOI: 10.1080/10428194.2019.1672052
PMC: PMC6982547
OpenAlex: W2981308797
Cited by: 30
References: 52
Citations by year: 2026: 1 · 2024: 5 · 2023: 7 · 2022: 6 · 2021: 7 · 2020: 3
FWCI: 2.94
Type: journal article
Language: en
Open access: green
europepmc.org
Locations: Leukemia & lymphoma/Leukemia and lymphoma (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Cancer Institute (UM1CA186690, UM1CA186717, P30CA033572, P30CA047904, R50CA211241)
Topics: Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
Health Sciences › Medicine › Hematology › Acute Lymphoblastic Leukemia research
Health Sciences › Medicine › Hematology › Acute Myeloid Leukemia Research
Keywords: alisertib, MLN8237, Aurora A kinase inhibitor, vorinostat, histone deacetylase inhibitors, combination therapy, relapsed/refractory lymphoma, diffuse large B-cell lymphoma, Hodgkin's disease, dose-limiting toxicity, hematologic toxicity, recommended phase 2 dose, intermittent dosing
MeSH terms: Vorinostat, Azepines, Humans, Lymphoproliferative Disorders, Neoplasm Recurrence, Local, Pyrimidines, Histone Deacetylase Inhibitors, Aurora Kinase A

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Phase 1 study of the Aurora kinase A inhibitor alisertib (MLN8237) combined with the histone deacetylase inhibitor vorinostat in lymphoid malignancies

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