Evidence map›Paper›PMID 34251414›Full record

Trial reportBlood advances2021

Phase 3 randomized trial of chemotherapy with or without oblimersen in older AML patients: CALGB 10201 (Alliance).

Alison R Walker, Guido Marcucci, Jun Yin, William Blum, Wendy Stock, Jessica Kohlschmidt, Krzysztof Mrózek, Andrew J Carroll, Ann-Kathrin Eisfeld, Eunice S Wang and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Blood advances, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00085124 (A Phase III Study of Daunorubicin and Cytarabine +/- G3139), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
3.1field-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.

NCT00085124 phase3completednot on this map

A Phase III Study of Daunorubicin and Cytarabine +/- G3139 (Genasense, Oblimersen Sodium, NSC #683428, IND #58842), a BCL2 Antisense Oligodeoxynucleotide, in Previously Untreated Patients With Acute Myeloid Leukemia (AML) > / = 60 Years

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2003Enrolled500ConditionsAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13, q22), Adult Acute Myeloid Leukemia With t(15Armsoblimersen sodium, cytarabine, daunorubicin hydrochloride, laboratory biomarker analysis
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Advances in antisense oligonucleotide treatment for cancer.Japanese journal of clinical oncology · 2026
    Review
  3. Review
  4. RNA Splicing as a Therapeutic Target in Cancer.Annual review of pharmacology and toxicology · 2026
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  5. Review
  6. Article
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  11. Aberrant pre-mRNA processing in cancer.The Journal of experimental medicine · 2024
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  15. Article
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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

20 authors at 13 institutions in 1 country.

Alison R WalkerDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH.
Guido MarcucciGehr Family Center for Leukemia Research, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope Comprehensive Cancer Center, Duarte, CA.
Jun YinAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN.ORCID 0000-0003-3242-9664
William BlumDepartment of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA.
Wendy StockUniversity of Chicago Comprehensive Cancer Center, Chicago, IL.
Jessica KohlschmidtClara D. Bloomfield Center for Leukemia Outcomes Research, The Ohio State University Comprehensive Cancer Center, Columbus, OH.
Krzysztof MrózekClara D. Bloomfield Center for Leukemia Outcomes Research, The Ohio State University Comprehensive Cancer Center, Columbus, OH.
Andrew J CarrollDepartment of Genetics, University of Alabama at Birmingham, Birmingham, AL.
Ann-Kathrin EisfeldDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH.
Eunice S WangDepartment of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
Sawyer JacobsonAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN.
Jonathan E KolitzDepartment of Medicine, Zucker School of Medicine at Hofstra/Northwell, Lake Success, NY.
Mohan ThakuriSoutheast Clinical Oncology Research Consortium, National Cancer Institute Community Oncology Research Program, Cancer Care of Western North Carolina, Asheville, NC.
Grerk SutamtewagulHolden Comprehensive Cancer Center, University of Iowa, Iowa City, IA.ORCID 0000-0002-1311-6227
Ravi VijDivision of Hematology and Oncology, Washington University School of Medicine, St Louis, MO.
Robert K StuartDepartment of Medicine, Hollings Cancer Center, Medical University of South Carolina, Charleston, SC; and.
John C ByrdDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH.
Clara D BloomfieldDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH.
Richard M StoneDepartment of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, MA.
Richard A LarsonUniversity of Chicago Comprehensive Cancer Center, Chicago, IL.ORCID 0000-0001-9168-3203
The Ohio State University · USMayo Clinic · USUniversity of Chicago · USCancerCare · USCity of Hope · USEmory University · USHofstra University · USMedical University of South Carolina · USRoswell Park Comprehensive Cancer Center · USSoutheast Clinical Oncology Research Consortium · USUniversity of Alabama at Birmingham · USUniversity of Iowa · USWashington University in St. Louis · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI XIWEI WU · 1985 to 2026
$86.3M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
THE ALLIANCE NCTN BIOREPOSITORY AND BIOSPECIMEN RESOURCEU24CA196171 · NCI · WASHINGTON UNIVERSITY · PI Mine Cicek, Wendy Frankel · 2015 to 2026
$35.0M
Northwell Health NCORPUG1CA189850 · NCI · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI VINCENT P VINCIGUERRA · 2014 to 2026
$13.3M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
Medical University of South Carolina NCORP Minority/Underserved Community SiteUG1CA189848 · NCI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI Marvella Elizabeth Ford, Evan Michael Graboyes · 2014 to 2026
$11.0M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
Targeted Therapy for LeukemiaR35CA197734 · NCI · UNIVERSITY OF CINCINNATI · PI BYRD, JOHN C. · 2015 to 2021
$6.6M
ITSC for Leukemia: Novel Molecular strategies for NCTN "Individualized" TherapiesUG1CA233338 · NCI · UNIVERSITY OF CINCINNATI · PI BYRD, JOHN C. · 2019 to 2025
$4.5M
NCI NIH HHS P30 CA033572NCI NIH HHS R35 CA197734NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882NCI NIH HHS U24 CA196171NCI NIH HHS UG1 CA189848NCI NIH HHS UG1 CA189850NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA233180NCI NIH HHS UG1 CA233191NCI NIH HHS UG1 CA233327NCI NIH HHS UG1 CA233331NCI NIH HHS UG1 CA233338NCI NIH HHS UG1 CA233339
6 · The paper itself

Abstract

Overexpression of B-cell leukemia/lymphoma 2 (BCL2) renders acute myeloid leukemia (AML) cells resistant to chemotherapy and has been associated with unfavorable outcomes. Oblimersen (G3139) is a phosphorothioate 18-mer antisense oligonucleotide directed against the first 6 BCL2 codons. In a phase 1 study of AML patients treated with G3139, cytarabine, and daunorubicin induction with cytarabine consolidation, no antisense-related toxicity was reported, and BCL2 downregulation occurred in patients achieving complete remission. In this phase 3 trial, untreated older AML patients were randomized to cytarabine (100 mg/m2 per day on days 4-10) and daunorubicin (60 mg/m2 per day on days 4-6) followed by cytarabine consolidation (2000 mg/m2 per day on days 4-8) with (arm A) or without (arm B) G3139 (7 mg/m2 per day on days 1-10 [induction] or days 1-8 [consolidation]). A total of 506 patients were enrolled. No differences in toxicity were observed between arms. Estimated overall survival (OS) at 1 year was 43% for arm A and 40% for arm B (1-sided log rank P = .13), with no differences in disease-free (DFS; P = .26) or event-free survival (P = .80). Subgroup analyses showed patients age <70 years in arm A had improved OS by 1 month vs those in arm B (P = .04), and patients with secondary AML in arm A had better DFS vs those in arm B (P = .04). We conclude that addition of G3139 to chemotherapy failed to improve outcomes of older AML patients. However, more effective means of inhibiting BCL2 are showing promising results in combination with chemotherapy in AML. This trial was registered at www.clinicaltrials.gov as #NCT00085124.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsLeukemia, Myeloid, AcuteAgedCytarabineHumansThionucleotidesCytarabineoblimersenThionucleotides

Identifiers

PMID34251414
PMCPMC8288671
OpenAlexW3178765071

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.