Evidence map›Paper›PMID 35740603›Full record

ArticleCancers2022

Phase 1/2 Trial of CLAG-M with Dose-Escalated Mitoxantrone in Combination with Fractionated-Dose Gemtuzumab Ozogamicin for Newly Diagnosed Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms.

Colin D Godwin, Eduardo Rodríguez-Arbolí, Megan Othus, Anna B Halpern, Jacob S Appelbaum, Mary-Elizabeth M Percival, Paul C Hendrie, Vivian G Oehler, Siobán B Keel, Janis L Abkowitz and 4 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Cancers, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03531918 (A Single-Center Phase 1/2 Study of Single- or Fractioned-Dose Gemtuzumab Ozogamicin in Combination With G-CSF, Cladribine, Cytarabine, and Mitoxantrone for Previously Untreated Adult Acute Myeloid Leukemia or High-Grade Myeloid Neoplasm), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 30% 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.

NCT03531918 phase1 / phase2completednot on this map

A Single-Center Phase 1/2 Study of Single- or Fractioned-Dose Gemtuzumab Ozogamicin in Combination With G-CSF, Cladribine, Cytarabine, and Mitoxantrone for Previously Untreated Adult Acute Myeloid Leukemia or High-Grade Myeloid Neoplasm

TypeinterventionalSponsorFred Hutchinson Cancer CenterRan2018 to 2021Enrolled66ConditionsAcute Myeloid LeukemiaArmsCladribine, Cytarabine, Gemtuzumab Ozogamicin, Recombinant Granulocyte Colony-Stimulating Factor, Laboratory Biomarker Analysis
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Review
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

14 authors at 2 institutions in 1 country.

Colin D GodwinClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Eduardo Rodríguez-ArbolíClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Megan OthusPublic Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Anna B HalpernClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Jacob S AppelbaumClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Mary-Elizabeth M PercivalClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Paul C HendrieClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Vivian G OehlerClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Siobán B KeelClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Janis L AbkowitzClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Jason P CooperClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Ryan D CassadayClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Elihu H EsteyClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Roland B WalterClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.ORCID 0000-0002-9268-3341
University of Washington · USFred Hutch Cancer Center · US

Funding

RESEARCH TRAINING IN HEMATOLOGYT32HL007093 · NHLBI · UNIVERSITY OF WASHINGTON · PI Janis L Abkowitz · 1985 to 2026
$13.9M
CAREER DEVELOPMENT IN PEDIATRIC AND MEDICAL ONCOLOGYK12CA076930 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DAVIDSON, NANCY ELLEN, MESHINCHI, SOHEIL · 1997 to 2025
$13.1M
Alex's Lemonade Stand Young Investigator GrantAmerican Society of Clinical Oncology Young Investigator AwardNational Heart Lung and Blood Institute T32-HL007093NCI NIH HHS K12 CA076930NCI NIH HHS K12-CA076930NHLBI NIH HHS T32 HL007093Pfizer Sponsored Research Agreement
6 · The paper itself

Abstract

Gemtuzumab ozogamicin (GO) improves outcomes when added to intensive AML chemotherapy. A meta-analysis suggested the greatest benefit when combining fractionated doses of GO (GO3) with 7 + 3. To test whether GO3 can be safely used with high intensity chemotherapy, we conducted a phase 1/2 study of cladribine, high-dose cytarabine, G-CSF, and dose-escalated mitoxantrone (CLAG-M) in adults with newly diagnosed AML or other high-grade myeloid neoplasm (NCT03531918). Sixty-six patients with a median age of 65 (range: 19-80) years were enrolled. Cohorts of six and twelve patients were treated in phase 1 with one dose of GO or three doses of GO (GO3) at 3 mg/m

Indexed as

acute myeloid leukemia (AML)adultsantibody-drug conjugateCD33chemotherapyCLAG-Mgemtuzumab ozogamicinphase 1/2 trial

Identifiers

PMID35740603
PMCPMC9221325
OpenAlexW4282946382

What OpenQuestion holds

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LicenceCC BY
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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.