适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
研究概览
简要总结
Requests for single patient expanded access to ziftomenib monotherapy may be considered for eligible adult patients with Acute Lymphoblastic Leukemia (ALL) with KMT2A rearrangements, or Acute Myeloid Leukemia (AML), with KMT2A rearrangements, or frontline AML patients with NPM1 mutations.
To request access, use Responsible Party contact information provided in this record.
Expanded access for ziftomenib is only available in the United States.
详细描述
• Subsection Condition:
- NPM1 mutation in frontline AML patients
- KMT2A rearrangement in AML patients
- KMT2A rearrangement in ALL patients
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Diagnosed with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL).
- •Adult, ages 18+.
- •Has exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition. For newly diagnosed AML patients with either NPM1-mutant, or KMT2A-rearranged AML, ziftomenib therapy will be considered for patients not eligible for ongoing clinical trials. In the case of patients with KMT2A-rearranged AML, Expanded Access to ziftomenib will only be provided for use in combination with FDA-approved therapies currently under clinical investigation at Kura Oncology (e.g., venetoclax + azacitidine, cytarabine + daunorubicin).
- •Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations.
- •Meets any other pertinent medical criteria for access to the investigational drug, as established by Kura Oncology.
研究者
相似试验
Available
不适用
Expanded Access to TipifarnibHRAS Mutations or Peripheral T Cell Lymphoma (PTCL)NCT04809233Kura Oncology, Inc.
Available
不适用
Pre-approval Single-patient Expanded Access for Ritlecitinib (PF-06651600)Alopecia AreataNCT05522556Pfizer
Available
不适用
Pre-approval Single-patient Expanded Access for Talazoparib (PF-06944076)Metastatic Castration-Resistant Prostate CancerNCT05650476Pfizer
Available
不适用
Expanded Access to Zofin for Patients With COVID-19Covid19Corona Virus InfectionSARS (Severe Acute Respiratory Syndrome)Acute Respiratory Distress SyndromeNCT04657406ZEO ScientifiX, Inc.
Available
不适用
Expanded Access to MepseviiMucopolysaccharidosis VIISly SyndromeMPS VIINCT03775174Ultragenyx Pharmaceutical Inc