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临床试验 NCT06226571 针对Acute Myeloid Leukemias目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Syndax PharmaceuticalsA Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias I期 76
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临床试验NCT06226571旨在研究治疗，主要针对Acute Myeloid Leukemias。这是一项I期 干预性研究试验，目前试验状态为招募中。试验始于2024年5月21日，计划招募76名患者。该研究由Syndax Pharmaceuticals主导，预计于2027年2月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月17日。
简要概括
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.
详细描述
The Dose Escalation portion of this study will identify the maximum tolerated dose, or if different, the recommended Phase 2 dose of SNDX-5613 to be used in combination with intensive chemotherapy and in maintenance monotherapy following intensive chemotherapy in participants with newly diagnosed AML harboring alterations in KMT2A, NPM1, or NUP98 genes.
In the Dose Expansion portion of the study, safety and prelimin...
显示更多官方标题
A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes
疾病
Acute Myeloid Leukemias其他研究标识符
- SNDX-5613-0708
- 2024-514531-18-00 (欧盟试验 (CTIS) 编号)
NCT编号
实际开始日期
2024-05-21
最近更新发布
2026-02-17
预计完成日期
2027-02
计划入组人数
76
研究类型
干预性研究
试验分期 (阶段)
I期
试验状态
招募中
关键词
SNDX-5613
Lysine-specific Methyltransferase 2A
KMT2A/MLL
Nucleophosmin 1
NPM1
Nucleoporin 98
NUP98
AML
Lysine-specific Methyltransferase 2A
KMT2A/MLL
Nucleophosmin 1
NPM1
Nucleoporin 98
NUP98
AML
主要目的
治疗方法
分配方式
不适用
干预模型
序贯设计
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性SNDX-5613 Dose Escalation:
* Induction: Sequential cohorts of escalating dose levels of SNDX-5613 with chemotherapy regimen.
* Consolidation: Cohorts will receive high-dose cytarabine (HiDAC) chemotherapy followed by SNDX-5613.
* Maintenance Monotherapy: Cohorts will receive SNDX-5613.
Dose Expansion:
* Induction: SNDX-5613 at tolerated dose level with chemotherapy regimen.
* Consolidation: Cohorts will receive SNDX-5613 wi...显示更多 | SNDX-5613 Participants will receive SNDX-5613 orally during Induction, Consolidation, and Maintenance until meeting criteria for discontinuation. Chemotherapy Regimen Induction: Participants will receive an intravenous (IV), 2-drug combination of cytarabine and either daunorubicin or idarubicin. HiDAC Consolidation: Participants will receive HiDAC IV. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Dose Escalation: Number of Participants with Dose-limiting Toxicities | Up to Day 42 | |
Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Day 1 through 30 days after final dose (up to approximately 3 years) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Maximum Plasma Concentration (Cmax) of SNDX-5613 and Relevant Metabolites | Predose through Day 15 | |
Area Under the Plasma Concentration Versus Time Curve From Time 0 to t (AUC0-t) of SNDX-5613 and Relevant Metabolites | Predose through Day 15 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria.
- Previously untreated AML and eligible to receive intensive chemotherapy.
- KMT2Ar, NPM1c, or NUP98r mutations identified by local laboratory prior to the first dose of SNDX-5613.
- Eastern Cooperative Oncology Group performance status ≤2 and ≤1 if >65 years old .
- Adequate liver, kidney, and cardiac function.
- Diagnosis of acute promyelocytic leukemia.
- Clinically active central nervous system leukemia (blasts detected in cerebrospinal fluid, radiographic or clinical signs and symptoms).
- Fridericia's corrected QT interval (QTcF) >450 milliseconds (average of triplicate), diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
- Any gastrointestinal issue of the upper gastrointestinal tract that might affect oral drug absorption or ingestion.
- Cirrhosis with a Child-Pugh score of B or C.
- Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.
- Hepatitis B, Hepatitis C, or HIV-positive with detectable viral load.
- Documented active, uncontrolled infection.
- Uncontrolled disseminated intravascular coagulation.
- Lactating/breast feeding or pregnant.
- Use of prohibited concomitant chemotherapy, radiation therapy, or immunotherapy.
- Use of strong CYP3A4 inducers or inhibitors (except for Itraconazole, Ketoconazole, Posaconazole, or Voriconazole).
Syndax Pharmaceuticals研究中心联系人
联系人: Syndax Pharmaceuticals, 781-419-1400, [email protected]
46 位于 6 个国家/地区的研究中心
California
UCLA Medical Hematology, Burbank, California, 91505, United States
Gary Schiller, MD, 联系人, [email protected]
招募中
City of Hope Medical Center, Duarte, California, 91010, United States
Wirlen Elame, 联系人, 626-218-7451, [email protected]
Ibrahim Aldoss, M.D., 主要研究者
招募中
Florida
AdventHealth Blood & Marrow Transplant Center, Orlando, Florida, 32804, United States
Brian Parkin, MD, 联系人, [email protected]
招募中
Tampa General Hospital, Tampa, Florida, 33606, United States
David Swoboda, MD, 联系人, [email protected]
招募中
Georgia
Emory Winship Cancer Institute, Atlanta, Georgia, 30322, United States
William Blum, MD, 联系人, [email protected]
招募中
Illinois
University of Chicago, Chicago, Illinois, 60637, United States
Michael Thirman, MD, 联系人, [email protected]
招募中
Kentucky
University of Louisville Health Brown Cancer Center, Louisville, Kentucky, 40202, United States
Mohamed Hegazi, MD, 联系人, [email protected]
招募中
Norton Cancer Institute, St. Matthews Campus, Louisville, Kentucky, 40207, United States
Don Stevens, MD, 联系人, [email protected]
招募中
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States
Margaret Michaelian, 联系人, [email protected]
招募中
Michigan
University of Michigan, Ann Arbor, Michigan, 48109, United States
Dale Bixby, MD, 联系人, [email protected]
招募中
Minnesota
Allina Health Cancer Institute, Minneapolis, Minnesota, 55407, United States
Fiona He, MD, 联系人, [email protected]
招募中
Missouri
Washington University School of Medicine, St Louis, Missouri, 63110, United States
Dr. John DiPersio, 联系人, [email protected]
招募中
New York
Institution name: Northwell Health-Brany, Lake Success, New York, 11042, United States
David Chitty, MD, 联系人, [email protected]
招募中
Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Eytan Stein, MD, 联系人, [email protected]
招募中
University of Rochester Medical Center, Rochester, New York, 14642, United States
Jozal Moore, MD, 联系人, [email protected]
招募中
SUNY Upstate Medical University, Syracuse, New York, 13210, United States
Teresa Gentile, MD, 联系人, [email protected]
招募中
North Carolina
East Carolina University, Greenville, North Carolina, 27834, United States
Darla Liles, MD, 联系人, [email protected]
招募中
Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, 27157, United States
Timoth Pardee, MD, 联系人, [email protected]
招募中
Ohio
Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States
Moaath Mustafa Ali, MD, MPH, 联系人, [email protected]
招募中
Oregon
Oregon Health and Science University- Center for Hematologic Malignancies, Portland, Oregon, 97239, United States
Elie Traer, MD, 联系人, [email protected]
招募中
Pennsylvania
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, 15232, United States
Annie lm, MD, 联系人, [email protected]
招募中
South Carolina
MUSC Hollings Cancer Center (HCC), Charleston, South Carolina, 29425, United States
Praneeth Baratam, MD, 联系人, [email protected]
招募中
Texas
Baylor University Medical Center, Dallas, Texas, 75246, United States
Bradley Christensen, MD, 联系人, [email protected]
招募中
The University of Texas, MD Anderson Cancer Center, Houston, Texas, 77030, United States
Ghayas C. Issa, MD, 联系人, [email protected]
招募中
Utah
LDS Hospital - Intermountain Healthcare, Salt Lake City, Utah, 84143, United States
Bradley Hunter, MD, 联系人, [email protected]
招募中
West Virginia
West Virginia University, Morgantown, West Virginia, 26506, United States
Carl Shultz, MD, 联系人, [email protected]
招募中
Victoria
Northern Hospital, Victoria, Epping, Victoria, 3076, Australia
Rhiannon Davidson, 联系人, [email protected]
招募中
Western Australia
Royal Perth Hospital, Perth, Western Australia, 6000, Australia
Megan Margaria, 联系人, [email protected]
招募中
Royal Adelaide Hospital, Adelaide, SA 5000, Australia
Devendra Keshaorao Hiwase, MD, 联系人, [email protected]
招募中
Sir Charles Gairdner Hospital, Nedlands, 6009, Australia
Carolyn Suzanne Groves, 联系人, [email protected]
招募中
Alberta
University of Alberta Hospital, Edmonton, Alberta, T6G 2B7, Canada
Joseph Brandwein, MD, 联系人, [email protected]
招募中
British Columbia
Gordon and Leslie Diamond Health Care Center, Vancouver, British Columbia, V5Z 1M9, Canada
Ryan Stubbins, MD, 联系人, [email protected]
招募中
Quebec
The Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, H3T 1E2, Canada
Sarit Assouline, MD, 联系人, [email protected]
招募中
University Medical Center Utrecht, Utrecht, 3584, Netherlands
Anna Van Rhenen, 联系人, [email protected]
招募中
Cantabria
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, 39008, Spain
Pilar Gonzalez, 联系人, [email protected]
招募中
Hospital Clinic de Barcelona, Barcelona, 8036, Spain
Alejandro Pardines Juan, 联系人, [email protected]
招募中
Hospital San Pedro de Alcantara, Cáceres, 10003, Spain
Ana Rodriguez Garcia, 联系人, [email protected]
招募中
Hospital Universitario Virgen de Las Nieves, Granada, 18014, Spain
Africa Vigo, 联系人, [email protected]
招募中
Hospital General Universitario Gregorio Marañon, Madrid, 28007, Spain
Ana Garcia, 联系人, [email protected]
招募中
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
Carolina Juez Gastañaga, 联系人, [email protected]
招募中
Hospital Universitario De Salamanca, Salamanca, 37007, Spain
Maria V Vicente, 联系人, [email protected]
招募中
Hospital Universitario Virgen del Rocio - PPDS, Seville, 41013, Spain
Laura Mora Boza, 联系人, [email protected]
招募中
London, City of
Hammersmith Hospital, London, London, City of, W12 0HS, United Kingdom
Neil Simpson, 联系人, [email protected]
招募中