NCT00006223已完成3 期
A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 91
研究概览
简要总结
RATIONALE: Drugs such as flt3L may stimulate a person's immune system and help kill cancer cells. It is not yet known if flt3L is effective in treating acute myeloid leukemia.
PURPOSE: Randomized phase III trial to determine the effectiveness of flt3L in treating patients who have acute myeloid leukemia that is in remission.
详细描述
OBJECTIVES:
- Compare the failure-free survival and overall survival in patients with acute myeloid leukemia in complete remission treated with maintenance flt3 ligand vs observation alone.
- Compare the long-term immunologic effects of these regimens in these patients.
- Compare the long-term safety and toxicity of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to complete remission (CR) (first vs second vs third or subsequent) and post-remission therapy (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive flt3 ligand subcutaneously daily on days 1-14. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation alone. Patients begin treatment or observation within 4 weeks after documentation of CR after induction therapy or within 4 weeks after discharge from hospital after post-remission therapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of acute myeloid leukemia in first, second, third, or subsequent complete remission (CR)
- •Must be at least 60 years of age if first CR
- •Must have had histological proof (from bone marrow aspirate, smears, or touch preps of marrow biopsy) of one of the following prior to achieving CR:
- •Acute myeloblastic leukemia (M0, M1, M2)
- •Acute promyelocytic leukemia (M3)
- •Acute myelomonocytic leukemia (M4)
- •Acute monocytic leukemia (M5)
- •Acute erythroleukemia (M6)
- •Acute megakaryocytic leukemia (M7)
- •Refractory anemia with excess blasts in transformation
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin less than 3 times upper limit of normal (ULN)
- •SGOT less than 3 times ULN
- •Creatinine less than 2 mg/dL
- •Cardiovascular:
- •No clinically significant active cardiac disease
- •No clinically significant active pulmonary disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No uncontrolled or active autoimmune disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior autologous bone marrow transplantation (BMT) allowed
- •No prior allogeneic BMT
- •Other prior immunotherapy allowed if not received during the most recent treatment
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供
研究者
研究点 (91)
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