A phase 2 study of belinostat (PXD101) in patients with relapsed or refractory acute myeloid leukemia or patients over the age of 60 with newly diagnosed acute myeloid leukemia: A California Cancer Consortium Study

Mark H. Kirschbaum, Kenneth A. Foon, Paul Frankel, Christopher Ruel, Bernadette Pulone, Joseph Tuscano, Edward M. Newman

Research output: Contribution to journalArticle

35 Citations (Scopus)

Abstract

We performed a phase II study of belinostat in patients with acute myeloid leukemia (AML). In this open label phase II study (NCT00357032), patients with relapsed/refractory AML, or newly diagnosed patients with AML over the age of 60, were eligible. Belinostat was administered intravenously (IV) at a dose of 1000 mg/m2 daily on days 15 of a 21-day cycle until progression or unacceptable toxicity. The primary endpoint was complete response (CR) rate, with secondary endpoints of overall response rate (CR partial response [PR]), time to treatment failure (TTF), overall survival and safety. Twelve eligible patients with AML were enrolled, of whom six had received at least one prior line of therapy. No CR or PR was seen. Four patients had stable disease for at least five cycles. Grade 3 non-hematological toxicities occurred in four patients. Belinostat as monotherapy has minimal single-agent effect in AML on this dosing schedule.

Original languageEnglish (US)
Pages (from-to)2301-2304
Number of pages4
JournalLeukemia and Lymphoma
Volume55
Issue number10
DOIs
StatePublished - Oct 1 2014

Fingerprint

Acute Myeloid Leukemia
Neoplasms
Treatment Failure
Reaction Time
belinostat
Appointments and Schedules
Safety
Survival

Keywords

  • Histone deacetylase inhibitor
  • Leukemia
  • Phase II

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

A phase 2 study of belinostat (PXD101) in patients with relapsed or refractory acute myeloid leukemia or patients over the age of 60 with newly diagnosed acute myeloid leukemia : A California Cancer Consortium Study. / Kirschbaum, Mark H.; Foon, Kenneth A.; Frankel, Paul; Ruel, Christopher; Pulone, Bernadette; Tuscano, Joseph; Newman, Edward M.

In: Leukemia and Lymphoma, Vol. 55, No. 10, 01.10.2014, p. 2301-2304.

Research output: Contribution to journalArticle

@article{66ec7858f1f2443dad946717b833b278,
title = "A phase 2 study of belinostat (PXD101) in patients with relapsed or refractory acute myeloid leukemia or patients over the age of 60 with newly diagnosed acute myeloid leukemia: A California Cancer Consortium Study",
abstract = "We performed a phase II study of belinostat in patients with acute myeloid leukemia (AML). In this open label phase II study (NCT00357032), patients with relapsed/refractory AML, or newly diagnosed patients with AML over the age of 60, were eligible. Belinostat was administered intravenously (IV) at a dose of 1000 mg/m2 daily on days 15 of a 21-day cycle until progression or unacceptable toxicity. The primary endpoint was complete response (CR) rate, with secondary endpoints of overall response rate (CR partial response [PR]), time to treatment failure (TTF), overall survival and safety. Twelve eligible patients with AML were enrolled, of whom six had received at least one prior line of therapy. No CR or PR was seen. Four patients had stable disease for at least five cycles. Grade 3 non-hematological toxicities occurred in four patients. Belinostat as monotherapy has minimal single-agent effect in AML on this dosing schedule.",
keywords = "Histone deacetylase inhibitor, Leukemia, Phase II",
author = "Kirschbaum, {Mark H.} and Foon, {Kenneth A.} and Paul Frankel and Christopher Ruel and Bernadette Pulone and Joseph Tuscano and Newman, {Edward M.}",
year = "2014",
month = "10",
day = "1",
doi = "10.3109/10428194.2013.877134",
language = "English (US)",
volume = "55",
pages = "2301--2304",
journal = "Leukemia and Lymphoma",
issn = "1042-8194",
publisher = "Informa Healthcare",
number = "10",

}

TY - JOUR

T1 - A phase 2 study of belinostat (PXD101) in patients with relapsed or refractory acute myeloid leukemia or patients over the age of 60 with newly diagnosed acute myeloid leukemia

T2 - A California Cancer Consortium Study

AU - Kirschbaum, Mark H.

AU - Foon, Kenneth A.

AU - Frankel, Paul

AU - Ruel, Christopher

AU - Pulone, Bernadette

AU - Tuscano, Joseph

AU - Newman, Edward M.

PY - 2014/10/1

Y1 - 2014/10/1

N2 - We performed a phase II study of belinostat in patients with acute myeloid leukemia (AML). In this open label phase II study (NCT00357032), patients with relapsed/refractory AML, or newly diagnosed patients with AML over the age of 60, were eligible. Belinostat was administered intravenously (IV) at a dose of 1000 mg/m2 daily on days 15 of a 21-day cycle until progression or unacceptable toxicity. The primary endpoint was complete response (CR) rate, with secondary endpoints of overall response rate (CR partial response [PR]), time to treatment failure (TTF), overall survival and safety. Twelve eligible patients with AML were enrolled, of whom six had received at least one prior line of therapy. No CR or PR was seen. Four patients had stable disease for at least five cycles. Grade 3 non-hematological toxicities occurred in four patients. Belinostat as monotherapy has minimal single-agent effect in AML on this dosing schedule.

AB - We performed a phase II study of belinostat in patients with acute myeloid leukemia (AML). In this open label phase II study (NCT00357032), patients with relapsed/refractory AML, or newly diagnosed patients with AML over the age of 60, were eligible. Belinostat was administered intravenously (IV) at a dose of 1000 mg/m2 daily on days 15 of a 21-day cycle until progression or unacceptable toxicity. The primary endpoint was complete response (CR) rate, with secondary endpoints of overall response rate (CR partial response [PR]), time to treatment failure (TTF), overall survival and safety. Twelve eligible patients with AML were enrolled, of whom six had received at least one prior line of therapy. No CR or PR was seen. Four patients had stable disease for at least five cycles. Grade 3 non-hematological toxicities occurred in four patients. Belinostat as monotherapy has minimal single-agent effect in AML on this dosing schedule.

KW - Histone deacetylase inhibitor

KW - Leukemia

KW - Phase II

UR - http://www.scopus.com/inward/record.url?scp=84907689730&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84907689730&partnerID=8YFLogxK

U2 - 10.3109/10428194.2013.877134

DO - 10.3109/10428194.2013.877134

M3 - Article

C2 - 24369094

AN - SCOPUS:84907689730

VL - 55

SP - 2301

EP - 2304

JO - Leukemia and Lymphoma

JF - Leukemia and Lymphoma

SN - 1042-8194

IS - 10

ER -