Evidence map›Paper›PMID 39584789›Full record

Trial reportCancer2025

Long-term follow-up of a phase 2 study of all-trans retinoic acid, arsenic trioxide, and gemtuzumab ozogamicin in acute promyelocytic leukemia.

Wei-Ying Jen, Jennifer Marvin-Peek, Hagop M Kantarjian, Yesid Alvarado, Gautam Borthakur, Elias Jabbour, William Wierda, Tapan M Kadia, Naval G Daver, Courtney D DiNardo and 26 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01409161 (Phase II Study of Treatment of Acute Promyelocytic 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
–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.

NCT01409161 phase2recruitingnot on this map

Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2011 to 2027Enrolled151ConditionsAcute Promyelocytic Leukemia With PML-RARAArmsArsenic Trioxide, Gemtuzumab Ozogamicin, Laboratory Biomarker Analysis, Tretinoin
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Article
  2. Article
  3. Significance of Vitamins A and E in Cancer Progression and Prevention.International journal of molecular sciences · 2025
    Review
  4. Review
  5. Review
  6. Article
  7. [The cure for acute promyelocytic leukemia and China's contributions].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025
    Review
  8. Review
  9. 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

36 authors.

Wei-Ying JenDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-9339-3362
Jennifer Marvin-PeekDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0001-9595-1279
Hagop M KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-1908-3307
Yesid AlvaradoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Gautam BorthakurDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Elias JabbourDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0003-4465-6119
William WierdaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Tapan M KadiaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-9892-9832
Naval G DaverDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0001-7103-373X
Courtney D DiNardoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0001-9003-0390
Nicholas J ShortDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-2983-2738
Nitin JainDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Alessandra FerrajoliDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Steven KornblauDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Musa YilmazDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Maro OhanianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
David McCueDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Jan BurgerDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Danielle HammondDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Keyur PatelDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Ghayas C IssaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Naveen PemmarajuDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-1670-6513
Koji SasakiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-9140-0610
Abhishek MaitiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Hussein A AbbasDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Kelly ChienDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0001-6024-1613
Koichi TakahashiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-8027-9659
Fadi HaddadDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-9702-8485
Prithviraj BoseDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-4343-5712
Lucia MasarovaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0001-6624-4196
Guillermo Montalban-BravoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-4533-5176
Mahesh SwaminathanDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0001-5959-397X
Mark BrandtDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Sherry PierceDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Guillermo Garcia-ManeroDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-3631-2482
Farhad RavandiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-7621-377X

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
University of Texas M.D. Anderson Cancer SPORE-LeukemiaP50CA100632 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI SHPALL, ELIZABETH J · 2003 to 2023
$43.7M
Charif Souki Cancer Research FundNCI NIH HHS P30 CA016672NCI NIH HHS P50 CA100632The University of Texas MD Anderson Cancer Center CA100632
6 · The paper itself

Abstract

backgroundAll-trans retinoic acid (ATRA) and arsenic trioxide (ATO) combinations have produced excellent outcomes in patients with standard-risk acute promyelocytic leukemia (APL). Herein, the authors update their long-term results with the regimen of ATO-ATRA and gemtuzumab ozogamicin (GO) in standard-risk and high-risk APL.

methodsThis was a phase 2 trial of patients with newly diagnosed APL. Induction comprised ATRA 45 mg/m

resultsOne hundred forty-six patients (median age, 53.0 years; range, 19.3-83.9 years) were treated, including 106 patients (72.6%) with standard-risk APL and 40 (27.4%) with high-risk APL. GO was administered to 68 standard-risk patients (64.2%) for leukocytosis. The complete remission rate was 93.8% (95% confidence interval [CI], 92.2%-98.5%). Negative measurable residual disease status was achieved in 97.1% of patients who attained complete remission. At a median follow-up of 61.8 months (95% CI, 4.7-128.4 months), the 5-year event-free survival, disease-free survival, and overall survival rates were 92.4% (95% CI, 87.9%-97.1%), 93.6% (95% CI, 89.5%-97.8%), and 93.1% (95% CI, 88.9%-97.7%), respectively. Induction mortality was 2.7%. The most common severe adverse events were elevated transaminases in 41.0% of patients and infection in 13.7%. There were no cases of veno-occlusive disease.

conclusionsThe combination of ATO-ATRA and GO was curative in 94% of patients who had APL with a favorable safety profile (ClinicalTrials.gov identifier NCT01409161).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsArsenic TrioxideGemtuzumabLeukemia, Promyelocytic, AcuteTretinoinAdultAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleMiddle AgedYoung AdultArsenic TrioxideGemtuzumabTretinoinacute promyelocytic leukemia (APL)all‐trans retinoic acid (ATRA)arsenic trioxide (ATO)clinical trialgemtuzumab ozogamicin (GO)

Identifiers

PMID39584789
PMCPMC11695139

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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.