NCT02312037No Longer Available不适用
GEMTUZUMAB OZOGAMICIN (MYLOTARG (REGISTERED)) EXPANDED ACCESS PROTOCOL FOR TREATMENT OF PATIENTS IN THE UNITED STATES WITH RELAPSED/REFRACTORY ACUTE MYELOGENOUS LEUKEMIA WHO MAY BENEFIT FROM TREATMENT AND HAVE NO ACCESS TO OTHER COMPARABLE/ALTERNATIVE THERAPY
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- Pfizer
- 试验地点
- 135
研究概览
简要总结
An expanded access/compassionate use protocol that allows access to Mylotarg for relapsed/refractory AML CD33 positive patients in the USA.
Contact: B1761026@iconplc.com
详细描述
Contact:
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of relapsed/refractory AML (defined as >=5% marrow blasts by morphology), including MDS, with persisting rising blasts and no other comparable or satisfactory alternative therapy available. If bone marrow has <5% blasts by morphology but the patient has evidence of relapse with extra-medullary disease progression. In select cases presenting with conversion of MRD from negative to positive, treatment with GO may be allowed where no alternative treatments are feasible.
- •Confirmed diagnosis of relapsed or refractory APL with persisting or rising leukemic burden (either by morphology, cytogenetic analysis or by molecular techniques), and no other comparable or satisfactory alternative therapy available.
- •Documentation that malignant cells express CD33
- •Age >=3 months
- •Adequate non-hematologic organ function
排除标准
- •Untreated AML and MDS or AML and MDS in complete remission.
- •Patients with a known history of VOD/SOS.
- •Patients with a known hypersensitivity to Mylotarg or its parts: hP67.6 antibody, calicheamicin derivatives or other ingredients.
- •Participation in other studies involving investigational drug(s) (Phases 1-4) during study participation.
研究者
研究点 (135)
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