Evidence map›Paper›PMID 38339248›Full record

ArticleCancers2024

Nivolumab Plus 5-Azacitidine in Pediatric Relapsed/Refractory Acute Myeloid Leukemia (AML): Phase I/II Trial Results from the Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) Consortium.

Anupam Verma, Yueh-Yun Chi, Jemily Malvar, Adam Lamble, Sonali Chaudhury, Archana Agarwal, Hong-Tao Li, Gangning Liang, Roy Leong, Patrick A Brown and 9 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancers, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03825367 (A Phase I/II Study of Nivolumab in Combination With 5-azacytidine in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
4.5field-weighted citation impact, top 5% 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.

NCT03825367 phase1 / phase2unknown statusnot on this map

A Phase I/II Study of Nivolumab in Combination With 5-azacytidine in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (BMS Reference CA209-9JY)

TypeinterventionalSponsorTherapeutic Advances in Childhood Leukemia ConsortiumRan2019 to 2024Enrolled13ConditionsAML, ChildhoodArmsNivolumab, 5-azacytidine
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
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  4. Molecularly targeted therapy and immunotherapy in leukemias.Journal of hematology & oncology · 2026
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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

19 authors at 14 institutions in 1 country.

Anupam VermaCenter for Cancer and Blood Disorders, Pediatric Hematology Oncology Branch, Children's National Hospital, Washington, DC 20010, USA.ORCID 0000-0001-6555-7924
Yueh-Yun ChiDivision of Hematology-Oncology, Cancer and Blood Disease Institute, Children's Hospital Los Angeles, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA 90027, USA.
Jemily MalvarDivision of Hematology-Oncology, Cancer and Blood Disease Institute, Children's Hospital Los Angeles, Los Angeles, CA 90027, USA.
Adam LambleDepartment of Pediatric Hematology Oncology, Seattle Children's Hospital, Seattle, WA 98105, USA.
Sonali ChaudhuryDepartment of Pediatric Hematology Oncology, Ann and Robert Lurie Children's Hospital of Chicago, Chicago, IL 60611, USA.
Archana AgarwalDepartment of Pathology, University of Utah and ARUP Laboratories, Salt Lake City, UT 84108, USA.
Hong-Tao LiDepartment of Urology, University of Southern California, Los Angeles, CA 90033, USA.ORCID 0000-0001-6366-0741
Gangning LiangDepartment of Urology, University of Southern California, Los Angeles, CA 90033, USA.
Roy LeongDivision of Hematology-Oncology, Cancer and Blood Disease Institute, Children's Hospital Los Angeles, Los Angeles, CA 90027, USA.
Patrick A BrownBristol Myers Squibb, Princeton, NJ 08543, USA.
Joel KaplanDepartment of Pediatric Hematology Oncology, Atrium Health Levine Children's Hospital, Wake Forrest University, Charlotte, NC 28203, USA.
Eric S SchaferDivision of Pediatric Hematology/Oncology, Baylor College of Medicine, Texas Children's Cancer and Hematology Center, Houston, TX 77030, USA.
Tamra SloneDepartment of Pediatric Hematology Oncology, UT Southwestern, Dallas, TX 75235, USA.
Melinda PaulyDepartment of Pediatric Hematology Oncology, Children's Healthcare of Atlanta, Atlanta, GA 30322, USA.
Bill H ChangDivision of Pediatric Hematology Oncology, Oregon Health and Science University, Portland, OR 97239, USA.ORCID 0000-0003-3783-1820
Elliot StieglitzDepartment of Pediatric Oncology, University of California, San Francisco Benioff Children's Hospitals, San Francisco, CA 94158, USA.ORCID 0000-0001-7032-4623
Alan S WayneDivision of Hematology-Oncology, Cancer and Blood Disease Institute, Children's Hospital Los Angeles, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA 90027, USA.
Nobuko HijiyaDivision of Pediatric Hematology Oncology and Stem Cell Transplant, Columbia University Medical Center, New York, NY 10032, USA.ORCID 0000-0002-0199-054X
Deepa BhojwaniDivision of Hematology-Oncology, Cancer and Blood Disease Institute, Children's Hospital Los Angeles, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA 90027, USA.
University of Southern California · USChildren's Hospital of Los Angeles · USBaylor College of Medicine · USBristol-Myers Squibb (United States) · USChildren's Healthcare of Atlanta · USColumbia University Irving Medical Center · USLevine Children's Hospital · USLurie Children's Hospital · USOregon Health & Science University · USPrimary Children's Hospital · USSeattle Children's Hospital · USThe University of Texas Southwestern Medical Center · USUniversity of California, San Francisco · USUniversity of Utah · US

Funding

Bristol Myers Squibb CA209-9JYGateway for Cancer Research G-17-500
6 · The paper itself

Abstract

Improvements in survival have been made over the past two decades for childhood acute myeloid leukemia (AML), but the approximately 40% of patients who relapse continue to have poor outcomes. A combination of checkpoint-inhibitor nivolumab and azacitidine has demonstrated improvements in median survival in adults with AML. This phase I/II study with nivolumab and azacitidine in children with relapsed/refractory AML (NCT03825367) was conducted through the Therapeutic Advances in Childhood Leukemia & Lymphoma consortium. Thirteen patients, median age 13.7 years, were enrolled. Patients had refractory disease with multiple reinduction attempts. Twelve evaluable patients were treated at the recommended phase II dose (established at dose level 1, 3 mg/kg/dose). Four patients (33%) maintained stable disease. This combination was well tolerated, with no dose-limiting toxicities observed. Grade 3-4 adverse events (AEs) were primarily hematological. Febrile neutropenia was the most common AE ≥ grade 3. A trend to improved quality of life was noted. Increases in CD8+ T cells and reductions in CD4+/CD8+ T cells and demethylation were observed. The combination was well tolerated and had an acceptable safety profile in pediatric patients with relapsed/refractory AML. Future studies might explore this combination for the maintenance of remission in children with AML at high risk of relapse.

Indexed as

acute myeloid leukemiacheckpoint inhibitorDNA methylationdose-limiting toxicityimmunotherapy

Identifiers

PMID38339248
PMCPMC10854518
OpenAlexW4391169552

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.