An Open Label, Pilot Phase II Study to Evaluate the Feasibility and Efficacy of CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 17
- 主要终点
- Number of Participants to Receive at Least One Cycle of Maintenance Therapy - Feasibility
研究概览
简要总结
The purpose of this research study is to find out what effects (the good and bad) the combination treatment of metformin and CPI-613 has in treating participants with acute myeloid leukemia or granulocytic sarcoma that has either returned after treatment or did not respond to treatment.
详细描述
Primary Objective: To establish the feasibility of delivering the combination of CPI-613 and metformin in patients with relapsed or refractory acute myeloid leukemia (AML).
Secondary Objectives: To determine the response rate of CPI-613 and metformin in relapsed or refractory AML defined as Complete remission (CR) + Complete remission with incomplete count recovery (CRi) + Morphologic Leukemia-Free State (MLFS).
- To determine the overall survival of patients with relapsed or refractory AML treated with CPI-613 and metformin.
- To determine the safety of CPI-613 and metformin in patients with relapsed or refractory acute myeloid leukemia (AML).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically documented relapsed and/or refractory Acute Myeloid Leukemia or granulocytic sarcoma.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤
- •Must be ≥ 18 years of age.
- •Persons of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
- •Persons who are having sexual relationships in which their partner may become pregnant must practice effective contraceptive methods during the study treatment and for 60 days after the last dose of study treatment, unless documentation of infertility exists.
- •Mentally competent, ability to understand and willingness to sign the informed consent form.
- •Patients with persisting, non-hematologic, non-infectious toxicities from prior treatment must be ≤ Grade 2 and must be documented as such.
- •Laboratory values ≤ 2 weeks prior to the start of study treatment must be the following:
- •Aspartate aminotransferase [AST/SGOT] ≤ 5x upper normal limit [UNL],
- •Alanine aminotransferase [ALT/SGPT] ≤ 5x UNL
- •Bilirubin ≤ 3x UNL
- •Albumin ≥ 2.0 g/dL or ≥ 20 g/L
- •Serum creatinine ≤ 2.0 mg/dL
- •Presence of central venous catheter or willing to have central venous access placed.
排除标准
- •Patients with active central nervous system (CNS) or epidural tumor.
- •Pregnant persons, or persons of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown).
- •Breastfeeding individuals because the potential of excretion of CPI-613 into breast milk. (Note: Breastfeeding individuals are excluded because the effects of CPI-613 on a nursing child are unknown).
- •Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patient.
- •Unwilling or unable to follow protocol requirements.
- •Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 1 week prior to initiation of CPI-613 treatment with the following exceptions:
- •The use of Hydrea or any targeted oral agent is allowed up to the day before initiation of treatment.
研究组 & 干预措施
Treatment - CPI-613 with Metformin
Induction therapy with CPI-613 and Metformin (ideally 2 hours prior to start of CPI-613 infusions on days 1-5) for two cycles of treatment.
Maintenance therapy with CPI-613 and Metformin (ideally 2 hours prior to start of CPI-613 infusions on days 1-5) until progression, intolerable toxicity of withdrawal of consent.
干预措施: CPI 613 (Drug)
Treatment - CPI-613 with Metformin
Induction therapy with CPI-613 and Metformin (ideally 2 hours prior to start of CPI-613 infusions on days 1-5) for two cycles of treatment.
Maintenance therapy with CPI-613 and Metformin (ideally 2 hours prior to start of CPI-613 infusions on days 1-5) until progression, intolerable toxicity of withdrawal of consent.
干预措施: Metformin (Drug)
Treatment - CPI-613 with Metformin
Induction therapy with CPI-613 and Metformin (ideally 2 hours prior to start of CPI-613 infusions on days 1-5) for two cycles of treatment.
Maintenance therapy with CPI-613 and Metformin (ideally 2 hours prior to start of CPI-613 infusions on days 1-5) until progression, intolerable toxicity of withdrawal of consent.
干预措施: Blood draws (Biological)
Treatment - CPI-613 with Metformin
Induction therapy with CPI-613 and Metformin (ideally 2 hours prior to start of CPI-613 infusions on days 1-5) for two cycles of treatment.
Maintenance therapy with CPI-613 and Metformin (ideally 2 hours prior to start of CPI-613 infusions on days 1-5) until progression, intolerable toxicity of withdrawal of consent.
干预措施: Bone marrow biopsy (Procedure)
结局指标
主要结局
Number of Participants to Receive at Least One Cycle of Maintenance Therapy - Feasibility
时间窗: After the completion of cycle 1 of maintenance therapy (maintenance cycle is 21 days)
Feasibility is defined as the ability to deliver at least 1 cycle of maintenance therapy in 50% or more of patients who complete induction therapy.
次要结局
- Response Rate - Efficacy (Acute Myeloid Leukemia European LeukemiaNet 2022)(After the completion of cycle 2 (each cycle is 14 days), then every three months up to 12 months)
- Number of Reported Adverse Events - Safety(Up to 30 days after last dose of study treatment)
- Overall Survival(Every 3 months after last dose of study treatment, up to 2 years)