Evidence map›Paper›PMID 26785287›Full record

ArticleFuture oncology (London, England)2016

Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia.

Gail J Roboz, Pau Montesinos, Dominik Selleslag, Andrew Wei, Jun-Ho Jang, Jose Falantes, Maria T Voso, Hamid Sayar, Kimmo Porkka, Paula Marlton and 6 more

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Future oncology (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
3.4field-weighted citation impact, top 8% of its field
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.

NCT01757535 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission

TypeinterventionalSponsorCelgeneRan2013 to 2024Enrolled472ConditionsLeukemia, Myeloid, AcuteArmsOral Azacitidine, Placebo
NCT04806906 phase2completednot on this mapstarted 2021, after this paper: background citation

A Phase 2, Monocentric, Pilot Study to Evaluate Safety and Efficacy of CC 486 (Oral Azacitidine) Plus Best Supportive Care as Maintenance of Response to sc Azacitidine in IPSS Higher Risk Elderly MDS Patients

TypeinterventionalSponsorUniversity of FlorenceRan2021 to 2025Enrolled11ConditionsMDS, CMMLArmsCC-486
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 39 citations in OpenAlex.

  1. Trial
  2. Phase I Study of CC-486 Alone and in Combination with Carboplatin or nab-Paclitaxel in Patients with Relapsed or Refractory Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2018
    Trial
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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

16 authors at 13 institutions in 8 countries.

Gail J RobozWeill Medical College of Cornell University & New York-Presbyterian Hospital, New York, NY, USA.
Pau MontesinosHospital Univeritari I Politecnic La Fe de Valencia, Valencia, Spain.
Dominik SelleslagAZ Sint-Jan AV, Brugge, Belgium.
Andrew WeiThe Alfred Hospital & Monash University, Melbourne, Australia.
Jun-Ho JangSamsung Medical Center, Seoul, South Korea.
Jose FalantesHospital Universitario Virgen del Rocio & Instituto de Biomedicinia de Sevilla, Seville, Spain.
Maria T VosoUniversita Cattolica del Sacro Cuore, Rome, Italy.
Hamid SayarIndiana University Cancer Center, Indianapolis, IN, USA.
Kimmo PorkkaHelsinki University Central Hospital, Helsinki, Finland.
Paula MarltonPrincess Alexandra Hospital, University of Queensland School of Medicine, Brisbane, Australia.
Antonio AlmeidaInstituto Portugues de Oncologia Francisco Gentil, Lisbon, Portugal.
Sanjay MohanVanderbilt University Medical Center, Nashville, TN, USA.
Farhad RavandiThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Guillermo Garcia-ManeroThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Barry SkikneCelgene Corporation, Overland Park, KS, USA.
Hagop KantarjianThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
The University of Texas MD Anderson Cancer Center · USAZ Sint-Jan · BEHelsinki University Hospital · FIHospital Universitari i Politècnic La Fe · ESHospital Universitario Virgen del Rocío · ESIndiana University – Purdue University Indianapolis · USInstituto Português de Oncologia Francisco Gentil · PTNew York Hospital Queens · USSamsung Medical Center · KRThe Alfred Hospital · AUThe University of Queensland · AUUniversità Cattolica del Sacro Cuore · ITVanderbilt University Medical Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
6 · The paper itself

Abstract

Older patients with acute myeloid leukemia (AML) have worse rates of complete remission and shorter overall survival than younger patients. The epigenetic modifier CC-486 is an oral formulation of azacitidine with promising clinical activity in patients with AML in Phase I studies. The Phase III, randomized, double-blind, placebo-controlled QUAZAR AML Maintenance trial (CC-486-AML-001) examines CC-486 maintenance therapy (300 mg/day for 14 days of 28-day treatment cycles) for patients aged ≥55 years with AML in first complete remission. The primary end point is overall survival. Secondary end points include relapse-free survival, safety, health-related quality of life and healthcare resource utilization. This trial will investigate whether CC-486 maintenance can prolong remission and improve survival for older patients with AML.

Indexed as

Administration, OralAntimetabolites, AntineoplasticAzacitidineClinical Trials, Phase III as TopicHumansLeukemia, Myeloid, AcuteMaintenance ChemotherapyMiddle AgedRandomized Controlled Trials as TopicAntimetabolites, AntineoplasticAzacitidineacute myeloid leukemiaCC-486de novoelderlymaintenance therapyoral azacitidinePhase IIIsecondary

Identifiers

PMID26785287
PMCPMC5684733
OpenAlexW2260812679

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.