Trial reportLeukemia2005
Gemtuzumab ozogamicin (Mylotarg) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups.
Trial report in Leukemia, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 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
23 citing papers in PubMed, 89 citations in OpenAlex.
- Four different regimens of farnesyltransferase inhibitor tipifarnib in older, untreated acute myeloid leukemia patients: North American Intergroup Phase II study SWOG S0432.Leukemia research · 2014Trial
- Phase II trial of vorinostat and gemtuzumab ozogamicin as induction and post-remission therapy in older adults with previously untreated acute myeloid leukemia.Haematologica · 2012Trial
- Report of a phase II study of clofarabine and cytarabine in de novo and relapsed and refractory AML patients and in selected elderly patients at high risk for anthracycline toxicity.The oncologist · 2011Trial
- 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).British journal of haematology · 2010Trial
- Targeted therapies in pediatric oncology: A start.Molecular therapy. Oncology · 2026Review
- Overcoming resistance to antibody-drug conjugates: from mechanistic insights to cutting-edge strategies.Journal of hematology & oncology · 2025Review
- Treatment-related adverse events of antibody-drug conjugates in clinical trials: A systematic review and meta-analysis.Cancer innovation · 2023Article
- Immunotherapy in Acute Myeloid Leukemia: Where We Stand.Frontiers in oncology · 2021Review
- Acute Myeloid Leukemia: Update on Upfront Therapy in Elderly Patients.Current oncology reports · 2019Review
- Antibody Based Therapies in Acute Leukemia.Current drug targets · 2017Review
- Successful repeated treatment of acute myeloid leukemia in early relapse with gemtuzumab ozogamicin alone.International journal of hematology · 2014Article
- Efficacy and resistance of gemtuzumab ozogamicin for acute myeloid leukemia.International journal of hematology · 2013Review
- Differences in drug approval processes of 3 regulatory agencies: a case study of gemtuzumab ozogamicin.Investigational new drugs · 2013Review
- Drug conjugates such as Antibody Drug Conjugates (ADCs), immunotoxins and immunoliposomes challenge daily clinical practice.International journal of molecular sciences · 2012Review
- Ara-C, Idarubicine and Gentuzumab Ozogamicin (AIM) as Salvage Treatment in Advanced Acute Myeloid Leukemia Patients.Mediterranean journal of hematology and infectious diseases · 2012Article
- Herceptin conjugates linked by EDC boost direct tumor cell death via programmed tumor cell necrosis.PloS one · 2011Article
- Immunotherapy prospects for acute myeloid leukaemia.Clinical and experimental immunology · 2010Review
- Targeted treatment of acute myeloid leukemia in older adults: role of gemtuzumab ozogamicin.Clinical interventions in aging · 2009Review
- Review
- The role of Gemtuzumab Ozogamicin in the treatment of acute myeloid leukemia patients.Oncogene · 2007Review
Corrections and comments
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Authors and funding
18 authors at 14 institutions in 5 countries.
Funding
Abstract
The therapeutic activity and toxicity profile of gemtuzumab ozogamicin were assessed in 40 patients >60 years of age with acute myeloid leukemia (AML) who were not considered eligible for conventional chemotherapy because of advanced age or poor performance status. The drug was administered at the dose of 9 mg/m2 as a single 2-h i.v. infusion on days 1 and 15. Patients who achieved a complete remission (CR/CRp) were to receive a consolidation with two additional injections of the immunotoxin at the same dose. The overall CR/CRp rate was 17% (95% CI, 8-32%). The CR/CRp rate in patients 61-75 years old was 33% (6/18), and 5% (1/22) in patients older than 75 years. Induction death occurred in seven patients (17%), all aged above 75 years. Overall survival was significantly longer in patients aged 61-75 years than in older individuals (P=0.05), and in CD33+ cases than in CD33- cases (P=0.05). We conclude that the dose/schedule of gemtuzumab ozogamicin used in this trial is too toxic in the age group over 75 years. For these patients, additional studies with reduced doses of the immunotoxin are warranted.
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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.