Treatment of Elderly AML Patients With Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells From Haploidentical Related Donors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Complete Remission (CR)
研究概览
简要总结
The purpose of this study is to test a method of bone marrow transplantation that results in only temporary donor immune function. In other words, the donor immune cells are given in a way that will allow them to attack leukemia briefly before being destroyed by their own immune system, or "rejected." The investigators want to test whether temporary donor immune function is enough to improve the odds of achieving a remission without exposing the patient to the toxicities of a full bone marrow transplant. To do this, the investigators will use standard chemotherapy for AML followed by an infusion of donor stem cells. The donor will be a family member who is haploidentically, or half matched, to the patient such as a child or sibling. Chemotherapy designed to treat AML should not be strong enough to prevent them from rejecting the donor stem cells. The investigators will then follow the patient to see how long the donor stem cells stay in them. The study will test whether this process is feasible and can result in improved chances of obtaining a remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a new diagnosis of histologically confirmed (according to WHO classification 2008) acute myeloid leukemia (either primary or secondary AML) are included.
- •Patients with a diagnosis of myelodysplastic syndrome with >/= 10% bone marrow blasts with no response or progression of disease after at least 4 cycles of a hypomethylating agent (5-azacytiine or decitabine).
- •Patients must have a healthy blood-related donor (parent, child, sibling) willing to undergo apheresis after G-CSF administration.
- •Karnofsky performance status > 70%.
- •Hepatic function - total bilirubin < 2 and, AST < 2.5 x upper limit of normal, unless liver is involved with disease or a history of Gilbert's disease.
- •Renal function - adequate renal function as demonstrated by a serum creatinine <2 mg/dl.
- •LVEF ≥ 50% as determined by echocardiogram or MUGA.
- •Ability to give informed consent.
- •Donor Eligibility:
- •Donor is blood-related and HLA-haploidentical to the recipient.
- •Donor ≥18 years old
- •Donor has undergone serologic testing for transmissible diseases as per blood banking guidelines for organ and tissue donors. Tests include but are not limited to: HepBsAg, HepBsAb, HepBcAb, HepC antibody, HIV, HTLV I and II, VZV, CMV and VDRL, and West Nile Virus . Donor must have normal negative test results for HIV, HTLV I and II, and West Nile Virus.
- •Donor has a CXR and EKG performed.
- •Donor is not allergic to G-CSF.
- •Donor must be able to undergo leukapheresis
- •Donor is not pregnant.
- •Donor does not have concurrent malignancy or autoimmune disease.
- •Ability to give informed consent.
排除标准
- •Patients with a diagnosis of acute promyelocytic leukemia (according to WHO classification 20080
- •Major surgery or irradiation within two weeks.
- •Previous therapy with cytotoxic agents for AML. Persons with previous treatments for myelodysplasia/myeloproliferation such as hydroxyurea, interferon, hypomethylating agents (5-azacitidine or decitabine), lenalidomide, or JAK/STAT inhibitors may participate but must have >1 week off therapy prior to enrollment.
- •Active CNS disease.
- •Uncontrolled infection.
- •Pregnant or lactating women - they are excluded, given the potential teratogenic effects of chemotherapy and agents used in the therapy.
- •Male and female patients of child-bearing potential unwilling to use effective means of contraception.
- •HIV or HTLV I/II seropositivity.
- •Concurrent active malignancy other than AML requiring therapy.
- •Clinically significant cardiac disease (NY Heart Association Class III or IV) or pulmonary disease.
- •Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests
- •Donor Exclusion:
- •Donor has cardiac risk factors precluding ability to undergo leukapheresis.
- •Donor has evidence of concurrent malignancy or autoimmune disease.
- •Donor is pregnant
研究组 & 干预措施
Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells
This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML.
干预措施: Induction Chemotherapy (Drug)
Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells
This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML.
干预措施: G-PBSC Infusion (Procedure)
结局指标
主要结局
Complete Remission (CR)
时间窗: 4 weeks
Peripheral Blood Counts: The peripheral blood neutrophil count should be ≥1,500/μl (sustained without growth factor support), and the platelets count should be ≥100,000/μl (without transfusion). No circulating blasts (in the absence of growth factor) should be detected. Bone Marrow Aspirate: The cellularity of the bone marrow should approximate normal. There must be evidence of maturation of all cell lines. The bone marrow aspirate should contain \< 5% blasts. Auer rods should not be detected. Extramedullary Leukemia: Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.
次要结局
未报告次要终点