Evidence map›Paper›PMID 26022709›Full record

Trial reportHaematologica2015

Randomized multicenter phase II study of flavopiridol (alvocidib), cytarabine, and mitoxantrone (FLAM) versus cytarabine/daunorubicin (7+3) in newly diagnosed acute myeloid leukemia.

Joshua F Zeidner, Matthew C Foster, Amanda L Blackford, Mark R Litzow, Lawrence E Morris, Stephen A Strickland, Jeffrey E Lancet, Prithviraj Bose, M Yair Levy, Raoul Tibes and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Haematologica, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01349972 (Randomized Phase II Trial of Timed Sequential Therapy), which is not on this map. Cited by 54 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 1 pooled it
7.8field-weighted citation impact, top 2% 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.

NCT01349972 phase2completednot on this map

Randomized Phase II Trial of Timed Sequential Therapy (TST) With Alvocidib (Flavopiridol), Ara-C and Mitoxantrone (FLAM) vs. "7+3" for Adults Age 70 and Under With Newly Diagnosed Acute Myelogenous Leukemia (AML)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2011 to 2014Enrolled172ConditionsAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b)Armsalvocidib, daunorubicin hydrochloride, mitoxantrone hydrochloride, cytarabine
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 1 synthesis or guideline pooled it, 102 citations in OpenAlex.

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  20. Targeting regulated cell death pathways in acute myeloid leukemia.Cancer drug resistance (Alhambra, Calif.) · 2023
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 1 country.

Joshua F ZeidnerThe Johns Hopkins Hospital, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA joshua_zeidner@med.unc.edu.
Matthew C FosterUniversity of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Amanda L BlackfordThe Johns Hopkins Hospital, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
Mark R LitzowMayo Clinic, Rochester, MN, USA.
Lawrence E MorrisThe Blood and Marrow Transplant Program at Northside Hospital, Bone Marrow Transplant Group of Georgia, Atlanta, GA, USA.
Stephen A StricklandVanderbilt-Ingram Cancer Center, Nashville, TN, USA.
Jeffrey E LancetH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Prithviraj BoseVirginia Commonwealth University, Massey Cancer Center, Richmond, VA, USA.
M Yair LevyTexas Oncology, Baylor Charles A. Simmons Cancer Center, Dallas, TX, USA.
Raoul TibesMayo Clinic, Scottsdale, AZ, USA.
Ivana GojoThe Johns Hopkins Hospital, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA University of Maryland Medical Center, Stewart Greenebaum Cancer Center, Baltimore, MD, USA.
Christopher D GockeThe Johns Hopkins Hospital, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
Gary L RosnerThe Johns Hopkins Hospital, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
Richard F LittleNational Cancer Institute, Rockville, MD, USA.
John J WrightNational Cancer Institute, Rockville, MD, USA.
L Austin DoyleNational Cancer Institute, Rockville, MD, USA.
B Douglas SmithThe Johns Hopkins Hospital, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
Judith E KarpThe Johns Hopkins Hospital, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
Johns Hopkins Hospital · USNational Cancer Institute · USMayo Clinic in Arizona · USSidney Kimmel Comprehensive Cancer Center · USHarold C. Simmons Comprehensive Cancer CenterMoffitt Cancer Center · USNorthside Hospital · USUniversity of Maryland, Baltimore · USUniversity of North Carolina at Chapel Hill · USVanderbilt University · USVirginia Commonwealth University · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
The Johns Hopkins Translational Science Team for the ET-CTNUM1CA186691 · NCI · JOHNS HOPKINS UNIVERSITY · PI Jan Hendrik Beumer, Michael A Carducci · 2014 to 2026
$21.9M
PHASE I TRIALS OF ANTICANCER AGENTSU01CA070095 · NCI · JOHNS HOPKINS UNIVERSITY · PI CARDUCCI, MICHAEL A · 1995 to 2013
$8.6M
Wisconsin and New Jersey Alliance in Precision Experimental TherapeuticsUM1CA186716 · NCI · RBHS -CANCER INSTITUTE OF NEW JERSEY · PI JABBOUR, SALMA, LIU, GLENN · 2014 to 2019
$4.1M
NCTN Lead Academic Participating Sites ApplicationU10CA180838 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A · 2014 to 2018
$2.8M
NCATS NIH HHS UL1 TR001079NCI NIH HHS 2P30 CA06973-46NCI NIH HHS P30 CA006973NCI NIH HHS U01 CA070095NCI NIH HHS U01 CA70095NCI NIH HHS U10 CA180838NCI NIH HHS UM1 CA186691NCI NIH HHS UM1 CA186716
6 · The paper itself

Abstract

Serial studies have demonstrated that induction therapy with FLAM [flavopiridol (alvocidib) 50 mg/m(2) days 1-3, cytarabine 667 mg/m(2)/day continuous infusion days 6-8, and mitoxantrone (FLAM) 40 mg/m(2) day 9] yields complete remission rates of nearly 70% in newly diagnosed poor-risk acute myeloid leukemia. Between May 2011-July 2013, 165 newly diagnosed acute myeloid leukemia patients (age 18-70 years) with intermediate/adverse-risk cytogenetics were randomized 2:1 to receive FLAM or 7+3 (cytarabine 100 mg/m(2)/day continuous infusion days 1-7 and daunorubicin 90 mg/m(2) days 1-3), across 10 institutions. Some patients on 7+3 with residual leukemia on day 14 received 5+2 (cytarabine 100 mg/m(2)/day continuous infusion days 1-5 and daunorubicin 45 mg/m(2) days 1-2), whereas patients on FLAM were not re-treated based on day 14 bone marrow findings. The primary objective was to compare complete remission rates between one cycle of FLAM and one cycle of 7+3. Secondary end points included safety, overall survival and event-free survival. FLAM led to higher complete remission rates than 7+3 alone (70% vs. 46%; P=0.003) without an increase in toxicity, and this improvement persisted after 7+3+/-5+2 (70% vs. 57%; P=0.08). There were no significant differences in overall survival and event-free survival in both arms but post-induction strategies were not standardized. These results substantiate the efficacy of FLAM induction in newly diagnosed AML. A phase III study is currently in development. This study is registered with clinicaltrials.gov identifier: 01349972.

Indexed as

Leukemia, Myeloid, AcuteAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCytarabineDaunorubicinDisease-Free SurvivalFemaleFlavonoidsFollow-Up StudiesHumansMaleMiddle AgedMitoxantronePiperidinesSurvival RatealvocidibCytarabineDaunorubicinFlavonoidsMitoxantronePiperidines

Identifiers

PMID26022709
PMCPMC4800702
OpenAlexW2177270897

What OpenQuestion holds

Textmetadata
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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.