NCT02331706已完成早期 1 期
A Pilot Study to Determine the Feasibility of Conventional Induction Chemotherapy Followed by G-CSF Mobilized Donor Leukocyte Infusion (DLI) and IFN-α (IFN-DLI) for Relapsed Acute Leukemia After Allogeneic Stem Cell Transplantation.
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This trial is designed to determine the feasibility of conventional induction chemotherapy, IFNand G-CSF mobilized DLI (IFN-DLI) in subjects with relapsed AML and ALL after allo-SCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •DLI Recipient
- •Relapsed AML or ALL ≥ 60 days after allogeneic SCT.
- •Evidence of residual donor chimerism on most recent analysis (within 4 weeks of enrollment).
- •Age ≥ 18 years of age,
- •Karnofsky performance status ≥ 60%.
- •Absence of active GVHD and off immunosuppression. Subjects on tapering prednisone will be eligible if their dose is 0.25 mg/kg or less and being actively tapered. We suggest a 28 day waiting period off of immunosuppression but some subjects with rapidly progressive disease may need to be treated before 30 days and will still be eligible.
- •Adequate organ function: Cr ≤ 2 mg/dL; ALT/AST < 3x ULN, direct bili <3x ULN.
- •Matched sibling or un-related donor (A, B, C, and DR) available to undergo leukopheresis.
- •Subjects must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
- •Willing to provide blood samples for research purposes.
- •Willing to adhere to medically accepted form of birth control to prevent pregnancy (includes: complete abstention from intercourse, condoms, diaphragms, cervical cap, intra-uterine device, history of surgical sterility - tubal ligation or vasectomy in patient or partner, or oral contraceptive).
- •HLA identical to recipient subject.
- •Considered medically eligible for leukopheresis procedure by independent donor physician (University of Pennsylvania physician who is not the recipient's primary transplant physician for related donors; physician designated by National Marrow Donor Program for unrelated donors).
- •Considered medically eligible to receive G-CSF (filgrastim) by independent donor physician.
- •Exclusion Criteria
- •Prior cell therapy for relapse within the past 90 days.
- •Requirement for active immunosuppression to treat GVHD.
- •Pregnant or lactating women. The safety of this therapy on unborn children and effects on breast milk are not known.
- •Uncontrolled active infection
- •Any uncontrolled active medical disorder that would preclude participation as outlined.
- •Unable to participate in a leukopheresis procedure or receive G-CSF (filgrastim).
排除标准
- 未提供
研究组 & 干预措施
Subject Recipients
Experimental
干预措施: Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily (Drug)
Subject Donors
Experimental
干预措施: Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: 2 years
次要结局
- disease-free survival(2 years)
- overall survival(2 years)
研究者
研究点 (1)
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