Trial reportCancer chemotherapy and pharmacology2023
A phase IV study evaluating QT interval, pharmacokinetics, and safety following fractionated dosing of gemtuzumab ozogamicin in patients with relapsed/refractory CD33-positive acute myeloid leukemia.
Trial report in Cancer chemotherapy and pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03727750 (A SINGLE ARM, OPEN-LABEL, PHASE 4 STUDY EVALUATING QT INTERVAL, PHARMACOKINETICS, AND SAFETY OF GEMTUZUMAB OZOGAMICIN), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
A single arm, open-label, phase 4 study evaluating qt interval, pharmacokinetics, and safety of gemtuzumab ozogamicin (mylotarg (trademarker)) as a single-agent regimen in patients with relapsed or refractory cd33-positive acute myeloid leukemia
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.
- QT Prolongation Risk of Antibody-Drug Conjugates.Drug safety · 2026Pooled it
- Payload-Based Clinical Pharmacology Review of Approved Antibody-Drug Conjugates: Commonalities and Considerations for Streamlined Development.Clinical pharmacology and therapeutics · 2026Review
- Antibody-Drug Conjugates Reshape the Landscape of Cancer Therapy: Evolution, Challenges and Future Perspectives from the Concept of "Magic Bullet" to Clinical Application.Current oncology reports · 2026Review
- Antibody-Drug Conjugates in Hematological Malignancies: Current Landscape and Future Perspectives.International journal of molecular sciences · 2026Review
- Lessons learned from QT prolongation risk assessment for antibody-drug conjugates in oncology.Journal of pharmacokinetics and pharmacodynamics · 2025Review
- A review of the clinical efficacy of FDA-approved antibody‒drug conjugates in human cancers.Molecular cancer · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeGemtuzumab ozogamicin (GO) is indicated for treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML). The QT interval, pharmacokinetics (PK), and immunogenicity following the fractionated GO dosing regimen have not been previously assessed. This phase IV study was designed to obtain this information in patients with R/R AML.
methodsPatients aged ≥ 18 years with R/R AML received the fractionated dosing regimen of GO 3 mg/m
resultsFifty patients received ≥ 1 dose of GO during Cycle 1. The upper limit of the 2-sided 90% confidence interval for least squares mean differences in QTc using Fridericia's formula (QTcF) was < 10 ms for all time points during Cycle 1. No patients had a post-baseline QTcF > 480 ms or a change from baseline > 60 ms. Treatment-emergent adverse events (TEAEs) occurred in 98% of patients; 54% were grade 3-4. The most common grade 3-4 TEAEs were febrile neutropenia (36%) and thrombocytopenia (18%). The PK profiles of both conjugated and unconjugated calicheamicin mirror that of total hP67.6 antibody. The incidence of antidrug antibodies (ADAs) and neutralizing antibodies was 12% and 2%, respectively.
conclusionFractionated GO dosing regimen (3 mg/m TRIAL REGISTRY: Clinicaltrials.gov ID: NCT03727750 (November 1, 2018).
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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.