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clinical / clinicalquizartinib QUANTUM-First, AML clinical trials, biomarkers, patient-centered AML

Gail J. Roboz

盖尔·罗博兹

MD

🏢Weill Cornell Medicine / NewYork-Presbyterian Hospital(威尔康奈尔医学院 / 纽约长老会医院)🌐USA

Professor of Medicine and Director, Leukemia Program, Weill Cornell Medicine; Attending Physician, NewYork-Presbyterian Hospital威尔康奈尔医学院医学教授兼白血病项目主任;纽约长老会医院主治医师

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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Gail J. Roboz, MD is Professor of Medicine and Director of the Leukemia Program at Weill Cornell Medicine and Attending Physician at NewYork-Presbyterian Hospital in New York City. She is one of the most prolific and innovative AML clinical trialists in the United States, widely recognized for her commitment to advancing treatment for difficult-to-treat AML populations and for her work on novel therapeutics across multiple disease subtypes. Dr. Roboz is a principal investigator in the landmark QUANTUM-First trial — the phase III study of quizartinib (a selective FLT3-ITD inhibitor) added to standard induction and consolidation chemotherapy in newly diagnosed FLT3-ITD-positive AML — which demonstrated significantly improved overall survival (HR 0.78; p=0.032) versus placebo, leading to FDA approval of quizartinib in July 2023. She has been a key investigator in multiple pivotal trials of CPX-351 (liposomal daunorubicin+cytarabine) in secondary AML, sapacitabine in elderly AML, and has led numerous early-phase trials at Weill Cornell exploring novel compounds. Dr. Roboz is also recognized for her pioneering work on AML response criteria and MRD assessment, co-chairing the ELN MRD Working Party and leading efforts to standardize MRD endpoints in AML trials. She is known for her energetic mentorship, patient advocacy, and as a frequent public communicator about AML, and has authored over 250 publications.

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🧪Research Fields 研究领域

Quizartinib — QUANTUM-First Trial in Newly Diagnosed FLT3-ITD AML奎扎替尼——QUANTUM-First试验在新诊断FLT3-ITD AML中的应用
Novel AML Therapies — Clinical Trials in Relapsed/Refractory and Older Patient AMLAML新型疗法——复发/难治性及老年AML患者的临床试验
MRD Assessment and Response Criteria in AML Clinical TrialsAML临床试验中的MRD评估与反应标准
Sapacitabine, CPX-351, and Emerging Agents in AML沙帕西他滨、CPX-351与AML中的新兴药物
Patient-Centered Outcomes and Shared Decision-Making in AMLAML中以患者为中心的结局与共同决策

🎓Key Contributions 主要贡献

QUANTUM-First Trial — Quizartinib in Newly Diagnosed FLT3-ITD AML

Served as a principal investigator in the phase III QUANTUM-First trial demonstrating that quizartinib added to standard induction and consolidation chemotherapy significantly improved overall survival (HR 0.78; median OS 31.9 vs. 15.1 months; p=0.032) in newly diagnosed FLT3-ITD-positive AML versus placebo — establishing quizartinib as only the second FLT3 inhibitor (after midostaurin) to demonstrate front-line survival benefit in AML and leading to FDA approval of quizartinib in July 2023.

CPX-351 in Secondary AML — Pivotal Trial Leadership

Was a key investigator in the phase III trial of CPX-351 (liposomal daunorubicin+cytarabine) versus standard 7+3 in older patients with newly diagnosed high-risk and secondary AML, demonstrating improved OS (9.56 vs. 5.95 months; HR 0.69; p=0.003) and remission rates — results that led to the 2017 FDA approval of CPX-351 (Vyxeos) for secondary AML and established a new standard in this difficult-to-treat population.

AML MRD Standardization — ELN MRD Working Party Leadership

Co-chaired the ELN MRD Working Party, leading international consensus efforts to standardize MRD definitions, assay requirements, and clinical reporting in AML across flow cytometry, PCR, and next-generation sequencing platforms. This work produced the authoritative ELN MRD consensus recommendations published in Blood (2018) that are now required for regulatory-grade AML trial design.

Patient-Centered AML Research — Quality of Life and Shared Decision-Making

Has pioneered patient-centered approaches in AML, incorporating quality-of-life endpoints, patient-reported outcomes, and shared decision-making frameworks into clinical trial design and clinical practice. Dr. Roboz has been a vocal advocate for centering patient preferences in AML treatment decisions, particularly for older patients facing the trade-off between intensive and non-intensive therapy.

Representative Works 代表性著作

[1]

Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-ITD+ AML (QUANTUM-First)

Lancet (2023)

Phase III QUANTUM-First trial showing quizartinib improved OS in newly diagnosed FLT3-ITD+ AML, supporting FDA approval of quizartinib in this setting.

[2]

CPX-351 (cytarabine and daunorubicin) Liposome Injection Versus Conventional Cytarabine Plus Daunorubicin in Older Patients With Newly Diagnosed Secondary AML

Journal of Clinical Oncology (2018)

Phase III trial demonstrating CPX-351 improved OS over conventional 7+3 in older patients with high-risk/secondary AML, supporting 2017 FDA approval.

[3]

Measurement of residual disease in acute myeloid leukemia: international consensus document from the European LeukemiaNet MRD Working Party

Blood Advances (2021)

ELN MRD consensus recommendations for AML co-authored by Roboz, standardizing MRD definitions and assay requirements for clinical trials and practice.

[4]

Phase 2 randomized trial of sapacitabine in elderly patients with AML

Blood (2018)

Randomized phase II study of sapacitabine alternating with decitabine versus decitabine alone in elderly AML, informing low-intensity combination design.

🏆Awards & Recognition 奖项与荣誉

🏆NCCN AML Guidelines Panel Member
🏆ELN MRD Working Party Co-Chair
🏆ASH Plenary Session Speaker
🏆Weill Cornell Medicine Leukemia Program Director
🏆American Cancer Society Research Scholar

📄Data Sources 数据来源

Last updated: 2026-04-06 | All information from publicly available academic sources

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