NCT03679650进行中（未招募）1 期
A Phase I Clinical Trial of Dendritic Cell/AML Fusion Cell Vaccine Alone and in Conjunction With Decitabine Following Allogeneic Transplantation in AML Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- The fold-increase in AML specific T cells in the peripheral blood and bone marrow
研究概览
简要总结
This research study is studying a cancer vaccine called Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) as a possible treatment for Acute Myelogenous Leukemia (AML).
The interventions involved in this study are:
- Dendritic Cell/AML Fusion vaccine (DC/AML vaccine)
- Decitabine, a chemotherapy drug
详细描述
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. This study is investigating the DC/AML vaccine with and without the drug decitabine as a possible treatment for AML in the post-transplant setting.
The FDA (the U.S. Food and Drug Administration) has not approved the DC/AML vaccine as a treatment for any disease.
The FDA has approved decitabine as a treatment option for this disease.
The FDA has not approved the combination of the DC/AML vaccine with decitabine as a treatment option for any disease,
In this research study, the investigators are determining if the DC/AML vaccine can be used safely in subjects with acute leukemia after they have undergone a transplant, and whether the DC/AML vaccine alone is capable of producing immune responses against leukemia. Cancer cells are foreign to the body and have unique markers that distinguish them from normal cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with AML who have undergone AML cell harvest and cryopreservation as per protocol 16-593 or companion protocol 18-
- •Patients must have had a minimum of 5x107 cells cryopreserved.
- •Patients must be day 25-45 following allogeneic transplantation from either:
- •Group A: HLA 8/8 or 7/8 matched related donor or HLA 8/8 matched unrelated donor, as determined by antigen or allele level typing at HLA A,B,C, and HLA DRB
- •Group B: Haplo-identical donor
- •Patients must be ≥ 18 years old
- •ECOG performance status ≤2 (Appendix A)
- •Participants must have normal organ and marrow function as defined below:
- •Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease)
- •AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal
- •Creatinine ≤ 2.0 mg/dl
- •Absolute neutrophil count > 1000
- •Platelet count > 50,000
- •The effects of DC/AML fusion cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •No evidence of ongoing grade 2 or higher aGVHD
- •Must be on prednisone <20mg or other steroid equivalent
- •Donor chimerism of bone marrow >60%
- •Resolution of all transplant related grade III-IV toxicity as per CTC criteria 4.0
- •Complete remission defined by absence of circulating blasts and less than 5% blasts in the bone marrow
- •Ability to understand and the willingness to sign a written informed consent document.
- •Eligibility Prior to Initiating Vaccination (Groups A and B)
- •Assessments to be done between Day 45-75 post-transplant.
- •At least 2 doses of fusion vaccine were produced
- •No ongoing grade II-IV acute GVHD
- •Prednisone requirement of < 20mg a day or steroid equivalent
- •Participants must have normal organ and marrow function as defined below:
- •Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease)
- •AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal
- •Creatinine ≤ 2.0 mg/dl
- •Absolute neutrophil count > 1000
- •Platelet count > 50,000
- •No uncontrolled acute infection
- •No CTCAE grade ≥ 3 non-hematologic toxicity
- •No serious intercurrent illness such as active acute infection, or significant cardiac disease characterized by clinically significant arrhythmia, active ischemic coronary disease or symptomatic congestive heart failure.
- •Participants must be in a complete remission
- •Pre-Treatment Criteria Prior to Decitabine (Group A Cohort 2)
- •Assessments to be done within 3 days prior to initiation of therapy.
- •Participants must have normal organ and marrow function as defined below:
- •Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease)
- •AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal
- •Creatinine ≤ 2.0 mg/dl
- •Absolute neutrophil count > 1000
- •Platelet count > 50,000
排除标准
- •Because of compromised cellular immunity, patients with a known history of HIV are excluded
- •Leukemia with active CNS involvement
- •Patients must not be pregnant. All premenopausal patients will undergo pregnancy testing. Men will agree to not father a child while on protocol treatment. Men and women will practice effective birth control while receiving protocol treatment.
- •Participants may not be receiving any other Non-FDA approved study agents at the start of vaccination
- •Uncontrolled intercurrent illness including uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
- •Autoimmune or inflammatory disorders requiring active treatment with systemic steroids or immunosuppressive therapy limited to the following:
- •GI Disorders: (including inflammatory bowel disease [e.g., ulcerative colitis, Crohn's disease]
- •Systemic lupus erythematosus
- •Wegener's syndrome [granulomatosis with polyangiitis]
- •Myasthenia gravis
- •Graves' disease
- •Rheumatoid arthritis
- •Hypophysitis
研究组 & 干预措施
AML Patient who are undergoing allogeneic transplantation
Experimental
- Patients will be vaccinated with DC/AML fusion cells
- Four days of GM-CSF given subcutaneously at the site of vaccination
- Patients will receive 2 vaccines, 3 weeks apart, with the potential for a booster vaccine
- Patients will be treated with 5 days of decitabine in the post-transplant setting
干预措施: decitabine (Drug)
AML Patient who are undergoing allogeneic transplantation
Experimental
- Patients will be vaccinated with DC/AML fusion cells
- Four days of GM-CSF given subcutaneously at the site of vaccination
- Patients will receive 2 vaccines, 3 weeks apart, with the potential for a booster vaccine
- Patients will be treated with 5 days of decitabine in the post-transplant setting
干预措施: DC/AML fusion cells (Biological)
AML Patient who are undergoing transplantation
Experimental
- Patients will be vaccinated with DC/AML fusion cells
- Four days of GM-CSF given subcutaneously at the site of vaccination
- Patients will receive 2 vaccines, 3 weeks apart, with the potential for a booster vaccine
干预措施: DC/AML fusion cells (Biological)
结局指标
主要结局
The fold-increase in AML specific T cells in the peripheral blood and bone marrow
时间窗: 12 months
次要结局
- Stable Disease(12 Months)
- Rate of Relapse(12 months)
- Relapse free survival(12 Months)
- Complete Remission(12 months)
- Complete Remission with Incomplete Count Recovery(12 Months)
- Complete Remission with Incomplete Platelet Recovery(12 months)
- Partial Remission (PR)(12 months)
研究者
Jacalyn Rosenblatt
Principal Investigator
Beth Israel Deaconess Medical Center
研究点 (4)
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