NCT04678466No Longer Available不适用
An Expanded Access Program Providing Flotetuzumab in the Treatment of Acute Myeloid Leukemia Patients in Single, Individually-approved Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- MacroGenics
研究概览
简要总结
The purpose of the Expanded Access program is to provide flotetuzumab to patients with acute myeloid leukemia (AML) for whom potential benefit justifies potential treatment risks.
详细描述
MacroGenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to flotetuzumab and for MacroGenics to supply flotetuzumab for single patient use.
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight of at least 17 kilograms
- •CD123-positive hematologic malignancy
- •Adequate organ reserve
- •Provider and site are trained on study protocol using flotetuzumab
排除标准
- •AML that meets inclusion criteria for study CP-MGD006-01 (NCT02152956)
- •Primary induction failure
- •Early relapse (less than 6 months after first complete remission )
- •Three prior lines of therapy, including maximum of 1 prior salvage attempts
研究者
相似试验
No Longer Available
不适用
Early Patient Access Treatment Use Protocol CA204-220Multiple MyelomaNCT02856438Bristol-Myers Squibb
No Longer Available
不适用
Expanded Access Treatment Protocol CA204-143Multiple MyelomaNCT02368301Bristol-Myers Squibb
Temporarily Not Available
不适用
Expanded Access to Telisotuzumab VedotinNon-Small Cell Lung Cancer (NSCLC)NCT04830202AbbVie
Approved For Marketing
不适用
Margetuximab Expanded Access ProgramNCT03133988TerSera Therapeutics LLC
Available
不适用
A Cohort IND Expanded Access Program for Supporting Patient Access to TebentafuspUveal MelanomaNCT04960891Immunocore Ltd