Trial reportBritish journal of haematology2010
Randomized trial of two schedules of low-dose gemtuzumab ozogamicin as induction monotherapy for newly diagnosed acute myeloid leukaemia in older patients not considered candidates for intensive chemotherapy. A phase II study of the EORTC and GIMEMA leukaemia groups (AML-19).
Trial report in British journal of haematology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 57 citations in OpenAlex.
- Population Pharmacokinetics of Gemtuzumab Ozogamicin in Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia.Clinical pharmacokinetics · 2019Trial
- Idarubicin and cytarabine in combination with gemtuzumab ozogamicin (IAGO) for untreated patients with high-risk MDS or AML evolved from MDS: a phase II study from the EORTC and GIMEMA Leukemia Groups (protocol 06013).Annals of hematology · 2015Trial
- Prospective phase II single-center study of the safety of a single very high dose of liposomal amphotericin B for antifungal prophylaxis in patients with acute myeloid leukemia.Antimicrobial agents and chemotherapy · 2013Trial
- Antibody-drug conjugates combinations in cancer treatment.Exploration of targeted anti-tumor therapy · 2024Review
- Treatment of Acute Myeloid Leukemia in Older Adults.Cancers · 2023Review
- Review
- Current Trends in Cancer Immunotherapy.Biomedicines · 2020Review
- Biomarkers of Gemtuzumab Ozogamicin Response for Acute Myeloid Leukemia Treatment.International journal of molecular sciences · 2020Review
- Targeting Immunophenotypic Markers on Leukemic Stem Cells: How Lessons from Current Approaches and Advances in the Leukemia Stem Cell (LSC) Model Can Inform Better Strategies for Treating Acute Myeloid Leukemia (AML).Cold Spring Harbor perspectives in medicine · 2020Review
- Lyon-University Hospital Experience with Gemtuzumab Ozogamicin Therapy in Acute Myeloid Leukemia: a 'Real-Life' Study.Mediterranean journal of hematology and infectious diseases · 2020Article
- Safety and Tolerability of Antibody-Drug Conjugates in Cancer.Drug safety · 2019Review
- Managing myelofibrosis (MF) that "blasts" through: advancements in the treatment of relapsed/refractory and blast-phase MF.Hematology. American Society of Hematology. Education Program · 2018Review
- Treatment of Elderly Patients With Acute Myeloid Leukemia.Current treatment options in oncology · 2017Review
- Complete response to gemtuzumab ozogamicin in a patient with refractory mast cell leukemia.Leukemia · 2016Article
- Management of Newly Diagnosed Acute Myeloid Leukemia in the Elderly: Current Strategies and Future Directions.Drugs & aging · 2015Review
- Novel drugs for older patients with acute myeloid leukemia.Leukemia · 2015Review
- Volasertib for AML: clinical use and patient consideration.OncoTargets and therapy · 2015Review
- Successful repeated treatment of acute myeloid leukemia in early relapse with gemtuzumab ozogamicin alone.International journal of hematology · 2014Article
- Can immunotherapy specifically target acute myeloid leukemic stem cells?Oncoimmunology · 2013Article
- Treatment of older patients with acute myeloid leukemia (AML): a Canadian consensus.American journal of blood research · 2013Article
Corrections and comments
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Authors and funding
17 authors at 12 institutions in 5 countries.
Funding
Abstract
This study compared two schedules of low-dose gemtuzumab ozogamicin (GO) as induction monotherapy for untreated acute myeloid leukaemia in older patients unfit for intensive chemotherapy, to identify the more promising regimen for further study. Patients were randomized to receive either best supportive care or a course of GO according to one of two schedules: 3 mg/m(2) on days 1, 3 and 5 (arm A), or GO 6 mg/m(2) on day 1 and 3 mg/m(2) on day 8 (arm B). Primary endpoint was the rate of disease non-progression (DnP), defined as the proportion of patients either achieving a response or maintaining a stable disease following GO induction in each arm. Fifty-six patients were randomized in the two GO arms (A, n = 29; B, n = 27). The rate of DnP was 38% [90% confidence interval (CI), 23-55] in arm A, and 63% (90% CI, 45-78) in arm B. Peripheral cytopenias were the most common adverse events for both regimens. The all-cause early mortality rate was 14% in arm A and 11% in arm B. The day 1 + 8 schedule, which was associated with the highest rate of DnP, met the statistical criteria to be selected as the preferred regimen for phase III comparison with best supportive care.
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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.