A Single-Arm, Open-Label Phase 1b Study of Hyper-CVAD + Calaspargase Pegol in Young Adults With Newly Diagnosed Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Mortality Rate of Hyper-CVAD after first infusion of calaspargase pegol
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed Philadelphia negative B- or T-cell acute lymphoblastic leukemia, with >10% peripheral blood or bone marrow lymphoblasts at diagnosis.
- •Treatment and full recovery from arm 1A of the Hyper-CVAD regimen.
- •Be willing and able to provide written informed consent/assent for the trial.
- •Able to adhere to the study visit schedule and other protocol requirements.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Cardiac ejection fraction ≥ 50% by echocardiography or MUGA, as measured prior to arm 1A of Hyper-CVAD.
- •Serum bilirubin and creatinine < 1.5x upper limit of normal (ULN). AST and ALT must be <3x ULN.
- •Females of childbearing potential (FCBP) must have a negative serum pregnancy test at screening. A FCBP is considered when a sexually mature female: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months.
- •A FCBP must agree to use of two methods of highly effective non-hormonal contraception, be surgically sterile, or abstain from heterosexual activity for the course of the study through 3 monthsafter the last dose of study treatment.
- •Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 30 days after the last dose of study therapy. Men must agree to not donate sperm during and after the study for 3 months
排除标准
- •Induction therapy with any regimen other than Hyper-CVAD 1A.
- •Diagnosis of L3 type Burkitt's lymphoma
- •Clinical evidence of active central nervous system (CNS) leukemia.
- •Any major surgery or radiation therapy within four weeks.
- •Diagnosis of Down Syndrome.
- •Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or Hepatitis C.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator (including but not limited to unstable angina, pre-existing liver disease, recurrent pancreatitis, uncontrolled diabetes, hypertriglyceridemia, pulmonary hypertension, or severeheart failure (New York Heart Association Class III-IV).
- •Recurrent thrombosis, or non-central venous catheter associated thrombosis within 3 months prior to enrollment.
- •Severe comorbid conditions for which life expectancy would be <6 months.
- •Patients with active (uncontrolled, metastatic) second malignancies are excluded.
- •Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.
研究组 & 干预措施
Hyper-CVAD + Calaspargase pegol Treatment
Participants will receive calaspargase pegol administered over 1 hour with each cycle of Hyper-CVAD, mini-CVD, and late intensification, beginning with Cycle 1B. Responding patients will have dose reduction of HyperCVAD for Cycles 2B-4B. Participants with CD20+ ALL will also be given Rituximab once per cycle.
干预措施: Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy) (Drug)
Hyper-CVAD + Calaspargase pegol Treatment
Participants will receive calaspargase pegol administered over 1 hour with each cycle of Hyper-CVAD, mini-CVD, and late intensification, beginning with Cycle 1B. Responding patients will have dose reduction of HyperCVAD for Cycles 2B-4B. Participants with CD20+ ALL will also be given Rituximab once per cycle.
干预措施: Calaspargase Pegol (Drug)
Hyper-CVAD + Calaspargase pegol Treatment
Participants will receive calaspargase pegol administered over 1 hour with each cycle of Hyper-CVAD, mini-CVD, and late intensification, beginning with Cycle 1B. Responding patients will have dose reduction of HyperCVAD for Cycles 2B-4B. Participants with CD20+ ALL will also be given Rituximab once per cycle.
干预措施: Rituximab (Drug)
结局指标
主要结局
Mortality Rate of Hyper-CVAD after first infusion of calaspargase pegol
时间窗: Up to 12 months
Mortality rate is hypothesized to be less than 10% when combining calaspargase pegol with Hyper-CVAD.
次要结局
- Overall Survival(Up to 42 months)
- Progression Free Survival(Up to 42 months)
- Minimal Residual Disease Remission Rate(Up to 3 years)