Evidence map›Paper›PMID 24369094›Full record

Trial reportLeukemia & lymphoma2014

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 M Tuscano, Edward M Newman

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Leukemia & lymphoma, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00357032 (A Phase 2 Study of PXD101 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia or Patients Over 60 With Newly-Diagnosed Acute Myelogenous Leukemia), which is not on this map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00357032 phase2completednot on this map

A Phase 2 Study of PXD101 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia or Patients Over 60 With Newly-Diagnosed Acute Myelogenous Leukemia

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2006 to 2010Enrolled12ConditionsAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13, q22)Armsbelinostat, laboratory biomarker analysis
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Mark H KirschbaumCity of Hope Comprehensive Cancer Center , Duarte, CA , USA.
Kenneth A Foon
Paul Frankel
Christopher Ruel
Bernadette Pulone
Joseph M Tuscano
Edward M Newman

Funding

VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Jessie Nedrow · 1988 to 2026
$158.0M
Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI STANLEY R. HAMILTON · 1985 to 2026
$86.3M
Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Laura Marcu · 2002 to 2026
$84.9M
Phase I Molecular and Clinical Pharmacodynamic Trials ETCTNUM1CA186717 · NCI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI A. Dimitrios Colevas, Alexey V. Danilov · 2014 to 2026
$19.8M
NCI NIH HHS P30 CA033572NCI NIH HHS P30 CA047904NCI NIH HHS P30CA047904NCI NIH HHS P30 CA093373NCI NIH HHS P30CA093373NCI NIH HHS UM1 CA186717
6 · The paper itself

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/m(2) daily on days 1-5 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.

Indexed as

AdultAgedAged, 80 and overAge FactorsAntineoplastic AgentsFemaleHistone Deacetylase InhibitorsHumansHydroxamic AcidsLeukemia, Myeloid, AcuteMaleMiddle AgedNeoplasm Recurrence, LocalSulfonamidesTreatment OutcomeAntineoplastic AgentsbelinostatHistone Deacetylase InhibitorsHydroxamic AcidsSulfonamidesHistone deacetylase inhibitorleukemiaphase II

Identifiers

PMID24369094
PMCPMC4143479

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.