Evidence map›Paper›PMID 42443407›Full record

Trial reportLeukemia2026

Randomized phase 2 trial of CPX-351 vs. CLAG-M (cladribine, cytarabine, G-CSF, and mitoxantrone) for medically unfit adults with acute myeloid leukemia or other high-grade myeloid neoplasms.

Anna B Halpern, Megan Othus, Mary-Elizabeth M Percival, Cristina Ghiuzeli, Jacob S Appelbaum, Paul C Hendrie, Ryan D Cassaday, Max Smith, Kathryn Russell, Bart L Scott and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04195945 (Randomized Phase 2 Trial of CPX-351), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT04195945 phase2completednot on this map

Randomized Phase 2 Trial of CPX-351 (Vyxeos) vs. CLAG-M (Cladribine, Cytarabine, G-CSF, and Mitoxantrone) in Medically Less-Fit Adults With Acute Myeloid Leukemia (AML) or Other High-Grade Myeloid Neoplasm

TypeinterventionalSponsorFred Hutchinson Cancer CenterRan2020 to 2026Enrolled60ConditionsAcute Myeloid Leukemia, Myeloid NeoplasmArmsLiposome-encapsulated Daunorubicin-Cytarabine, Cladribine, Cytarabine, Recombinant Granulocyte Colony-Stimulating Factor, Mitoxantrone
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

17 authors.

Anna B HalpernDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA. halpern2@uw.edu.ORCID http://orcid.org/0000-0002-4326-0748
Megan OthusPublic Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0001-8176-6371
Mary-Elizabeth M PercivalDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.
Cristina GhiuzeliDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.
Jacob S AppelbaumDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.
Paul C HendrieDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.
Ryan D CassadayDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.
Max SmithClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Kathryn RussellDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.
Bart L ScottDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.
Jason P CooperDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-0023-8054
Joshua R VeatchDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.
Siobán B KeelDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.
Vivian G OehlerDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.
Erik L KimbleDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.ORCID http://orcid.org/0000-0002-1885-1773
Raya MawadDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.
Roland B WalterDepartment of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA, USA.ORCID http://orcid.org/0000-0002-9268-3341

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Even with new drugs available, how best to treat unfit adults with acute myeloid leukemia (AML) remains uncertain. In a previous trial in such patients, we found high-dose cytarabine-based therapy with CLAG-M yielded higher response rates but no more toxicity than lower-intensity therapy with dose-attenuated CLAG-M. Here, we conducted a single-institution phase 2 trial (NCT04195945) randomizing 60 adults with untreated AML and medical unfitness with Treatment-Related Mortality (TRM) score of ≥13.1 (68% with ECOG performance status 3-4) 1:1 to standard-dose CPX-351 or CLAG-M. Primary endpoint was 3-month overall survival (OS); key secondary endpoints included overall response rate, rate of measurable residual disease (MRD) negativity, toxicity/mortality rates, and survival estimates. Only CLAG-M met the primary endpoint of ≥63% 3-month OS (70% vs. 60%; P = 0.41), and CLAG-M therapy was associated with a non-significantly higher complete remission (CR) plus CR with incomplete hematologic recovery rate (73% vs. 47%, P = 0.064). Nonetheless, there was no statistically significant difference in relapse-free survival following CLAG-M vs. CPX-351 (median 37.6 vs. 19.9 months; P = 0.80) or OS (median 10.5 vs. 5.8 months; P = 0.76). In patients with proliferative disease, however, OS following CLAG-M was longer (median 18.5 vs. 3.9 months; P = 0.02) suggesting a role for intensive therapy in this patient subset.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsLeukemia, Myeloid, AcuteAdultAgedCladribineCytarabineDaunorubicinFemaleGranulocyte Colony-Stimulating FactorHumansMaleMiddle AgedMitoxantronePrognosisSurvival RateYoung AdultCladribineCPX-351CytarabineDaunorubicinGranulocyte Colony-Stimulating FactorMitoxantrone

Identifiers

PMID42443407

What OpenQuestion holds

Textmetadata
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.