Trial reportAnnals of hematology2021
Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial.
Trial report in Annals of hematology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01546038 (A PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-04449913, AN ORAL HEDGEHOG INHIBITOR, IN COMBINATION WITH INTENSIVE CHEMOTHERAPY, LOW DOSE ARA-C OR DECITABINE IN PATIENTS WITH ACUTE MYELOID LEUKEMIA OR HIGH-RISK MYELODYSPLASTIC SYNDROME), which is not on this map. Cited by 41 papers, 4 of them syntheses 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 1b/2 study to evaluate the safety and efficacy of pf-04449913, an oral hedgehog inhibitor, in combination with intensive chemotherapy, low dose ara-c or decitabine in patients with acute myeloid leukemia or high-risk myelodysplastic syndrome
Who cites it
41 citing papers in PubMed, 4 syntheses or guidelines pooled it, 53 citations in OpenAlex.
- American Society of Hematology 2025 guidelines for treating newly diagnosed acute myeloid leukemia in older adults.Blood advances · 2026Guideline
- Indirect treatment comparison of ivosidenib and other therapies in patients with newly diagnosed acute myeloid leukemia.Future oncology (London, England) · 2025Pooled it
- Comparative efficacy and safety in low-intensity treatment for acute myeloid leukemia in older patients: a systematic review and network meta-analysis.European journal of medical research · 2025Pooled it
- Glasdegib combined with chemotherapy in the treatment of patients with acute myeloid leukemia: a comprehensive meta-analysis.Investigational new drugs · 2025Pooled it
- Glasdegib in combination with temozolomide and radiotherapy in adult patients with newly diagnosed glioblastoma: the phase Ib/II GEINO 1602 trial.Nature communications · 2025Trial
- An evaluation of overall survival in patients with newly diagnosed acute myeloid leukemia and the relationship with glasdegib treatment and exposure.Cancer chemotherapy and pharmacology · 2020Trial
- Frailty and Fitness in Older Adults With Acute Myeloid Leukemia: From Chronological Age to Multiparametric Assessment.European journal of haematology · 2026Review
- A proposed refined definition of acute myeloid leukaemia patients ineligible for intensive therapy: The Integrated Comorbidity-ECOG-Age criteria.British journal of haematology · 2026Article
- The Role of the Bone Marrow Microenvironment in the Pathogenesis of Acute Myeloid Leukemia.Biomedicines · 2026Review
- Management of Acute Myeloid Leukemia in Older Patients: An Updated Canadian Consensus.Current oncology (Toronto, Ont.) · 2026Article
- Review
- Risk factors for leukemic transformation in myeloproliferative neoplasms and prognostic factors in secondary acute myeloid leukemia: an exploratory analysis of the SEER database.Annals of hematology · 2026Article
- Review
- Molecularly targeted therapy and immunotherapy in leukemias.Journal of hematology & oncology · 2026Review
- Updates on Therapy Options in Fit and Unfit Patients with Newly Diagnosed AML.Current treatment options in oncology · 2025Review
- Evolving Paradigms in Acute Myeloid Leukemia: Personalized Approaches to Therapy Across Age and Risk Groups.Cancers · 2025Review
- Advances in the Treatment of Acute Myeloid Leukemia: Implications for Low- and Middle-Income Countries.Biomedicines · 2025Review
- Fitness assessment in acute myeloid leukemia: recommendations from an expert panel on behalf of the European LeukemiaNet.Blood advances · 2025Review
- Intensive Chemotherapy Versus Venetoclax-Based Regimens in Elderly Patients with Acute Myeloid Leukemia: Is the Chemotherapy Era Ending?Journal of clinical medicine · 2025Review
- Review
Corrections and comments
- Erratum issued
Authors and funding
16 authors at 11 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This analysis from the phase II BRIGHT AML 1003 trial reports the long-term efficacy and safety of glasdegib + low-dose cytarabine (LDAC) in patients with acute myeloid leukemia ineligible for intensive chemotherapy. The multicenter, open-label study randomized (2:1) patients to receive glasdegib + LDAC (de novo, n = 38; secondary acute myeloid leukemia, n = 40) or LDAC alone (de novo, n = 18; secondary acute myeloid leukemia, n = 20). At the time of analysis, 90% of patients had died, with the longest follow-up since randomization 36 months. The combination of glasdegib and LDAC conferred superior overall survival (OS) versus LDAC alone; hazard ratio (HR) 0.495; (95% confidence interval [CI] 0.325-0.752); p = 0.0004; median OS was 8.3 versus 4.3 months. Improvement in OS was consistent across cytogenetic risk groups. In a post-hoc subgroup analysis, a survival trend with glasdegib + LDAC was observed in patients with de novo acute myeloid leukemia (HR 0.720; 95% CI 0.395-1.312; p = 0.14; median OS 6.6 vs 4.3 months) and secondary acute myeloid leukemia (HR 0.287; 95% CI 0.151-0.548; p < 0.0001; median OS 9.1 vs 4.1 months). The incidence of adverse events in the glasdegib + LDAC arm decreased after 90 days' therapy: 83.7% versus 98.7% during the first 90 days. Glasdegib + LDAC versus LDAC alone continued to demonstrate superior OS in patients with acute myeloid leukemia; the clinical benefit with glasdegib + LDAC was particularly prominent in patients with secondary acute myeloid leukemia. ClinicalTrials.gov identifier: NCT01546038.
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.