Trial reportBlood2012
Phase 2 study of subcutaneous omacetaxine mepesuccinate after TKI failure in patients with chronic-phase CML with T315I mutation.
Trial report in Blood, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00375219 (A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine.), which is not on this map. Cited by 72 papers, 1 of them a synthesis that pooled 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.
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 Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine. (Omacetaxine) (CGX-635) in the Treatment of Patients With Chronic Myeloid Leukemia. (CML) With the T315I BCR-ABL Gene Mutation
Who cites it
72 citing papers in PubMed, 1 synthesis or guideline pooled it, 135 citations in OpenAlex.
- Analysis of Clinical Trials Using Anti-Tumor Traditional Chinese Medicine Monomers.Drug design, development and therapy · 2024Pooled it
- A phase II study of omacetaxine mepesuccinate for patients with higher-risk myelodysplastic syndrome and chronic myelomonocytic leukemia after failure of hypomethylating agents.American journal of hematology · 2019Trial
- Phase II trial of homoharringtonine with imatinib in chronic, accelerated, and blast phase chronic myeloid leukemia.Leukemia & lymphoma · 2017Trial
- A phase 2 study of MK-0457 in patients with BCR-ABL T315I mutant chronic myelogenous leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia.Blood cancer journal · 2014Trial
- Subcutaneous omacetaxine mepesuccinate in patients with chronic-phase chronic myeloid leukemia previously treated with 2 or more tyrosine kinase inhibitors including imatinib.Clinical lymphoma, myeloma & leukemia · 2013Trial
- Phase 2 study of subcutaneous omacetaxine mepesuccinate for chronic-phase chronic myeloid leukemia patients resistant to or intolerant of tyrosine kinase inhibitors.American journal of hematology · 2013Trial
- Omacetaxine and venetoclax in relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome with mutant RUNX1.Blood neoplasia · 2025Article
- Homoharringtonine: mechanisms, clinical applications and research progress.Frontiers in oncology · 2025Review
- Novel targeted therapies in chronic myeloid leukemia.Pharmaceutical science advances · 2024Review
- Recent developments in receptor tyrosine kinase inhibitors: A promising mainstay in targeted cancer therapy.Medicine in drug discovery · 2024Article
- SMYD5 is a ribosomal methyltransferase that catalyzes RPL40 lysine methylation to enhance translation output and promote hepatocellular carcinoma.Cell research · 2024Article
- Homoharringtonine: updated insights into its efficacy in hematological malignancies, diverse cancers and other biomedical applications.European journal of medical research · 2024Review
- Exploring treatment decision-making in chronic myeloid leukemia in chronic phase.Frontiers in oncology · 2024Review
- Definitions, Biology, and Current Therapeutic Landscape of Myelodysplastic/Myeloproliferative Neoplasms.Cancers · 2023Review
- Developing therapeutic approaches for chronic myeloid leukemia: a review.Molecular and cellular biochemistry · 2023Review
- Management of chronic myeloid leukemia in 2023 - common ground and common sense.Blood cancer journal · 2023Review
- Therapy for patients with chronic phase-chronic myeloid leukemia previously treated with ⩾2 tyrosine kinase inhibitors: a systematic literature review.Therapeutic advances in hematology · 2023Review
- Development and characterization of anti-fibrotic natural compound similars with improved effectivity.Basic research in cardiology · 2022Article
- Potential Antiviral Action of Alkaloids.Molecules (Basel, Switzerland) · 2022Review
- The Metabolic Signature of AML Cells Treated With Homoharringtonine.Frontiers in oncology · 2022Article
12 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 6 institutions in 5 countries.
Funding
Abstract
Chronic myeloid leukemia (CML) patients with the BCR-ABL T315I mutation do not benefit from therapy with currently approved tyrosine kinase inhibitors. Omacetaxine mepesuccinate is a protein synthesis inhibitor that has demonstrated activity in cells harboring the T315I mutation. This phase 2 trial assessed the efficacy of omacetaxine in CML patients with T315I and tyrosine kinase inhibitor failure. Patients received subcutaneous omacetaxine 1.25 mg/m(2) twice daily, days 1-14, every 28 days until hematologic response or a maximum of 6 cycles, and then days 1-7 every 28 days as maintenance. Results for patients treated in chronic phase are reported here. Patients (n = 62) received a median of 7 (range, 1-41) cycles. Complete hematologic response was achieved in 48 patients (77%; 95% lower confidence limit, 65%); median response duration was 9.1 months. Fourteen patients (23%; 95% lower confidence limit, 13%) achieved major cytogenetic response, including complete cytogenetic response in 10 (16%). Median progression free-survival was 7.7 months. Grade 3/4 hematologic toxicity included thrombocytopenia (76%), neutropenia (44%), and anemia (39%) and was typically manageable by dose reduction. Nonhematologic adverse events were mostly grade 1/2 and included infection (42%), diarrhea (40%), and nausea (34%). Omacetaxine may provide a safe and effective treatment for CML patients with T315I mutation. This study is registered at www.clinicaltrials.gov as NCT00375219.
Indexed as
Identifiers
What OpenQuestion holds
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.