Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Event-Free Survival
研究概览
简要总结
This phase II trial studies how well combination chemotherapy and inotuzumab ozogamicin work in treating patients with B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy and inotuzumab ozogamicin may work better at treating B acute lymphoblastic leukemia.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the clinical efficacy of the sequential combination of hyper-CVAD (hyperfractionated cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate and cytarabine) + inotuzumab ozogamicin in patients with newly diagnosed B-cell acute lymphocytic leukemia (ALL) in terms of event-free survival (EFS).
SECONDARY OBJECTIVES:
I. To evaluate other efficacy endpoints such as overall survival, overall response rate, minimal residual disease (MRD) negativity rate as well as the safety of this combination.
OUTLINE:
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed, previously untreated B-lineage ALL, or having achieved complete remission (CR) with one course of induction chemotherapy
- •Patients with extramedullary disease only are eligible
- •Failure to one induction course of chemotherapy (these patients will be analyzed separately)
- •Performance status of 0-3
- •Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)
- •Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related)
- •Adequate cardiac function as assessed by history and physical examination
- •No active or co-existing malignancy with life expectancy less than 12 months
- •Women of childbearing potential (WOCBP) or male subjects with a partner who is WOCBP must agree to use contraception during the study, if sexually active
排除标准
- •Pregnant or nursing women
- •Known to be human immunodeficiency virus (HIV)-positive
- •Philadelphia chromosome (Ph)-positive ALL
- •Active and uncontrolled disease/infection as judged by the treating physician
- •Unable or unwilling to sign the consent form
- •Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement or stable chronic liver disease per investigator assessment)
- •Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
研究组 & 干预措施
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Cyclophosphamide (Drug)
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Cytarabine (Drug)
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Leucovorin Calcium (Drug)
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Dexamethasone (Drug)
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Doxorubicin Hydrochloride (Drug)
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Inotuzumab Ozogamicin (Biological)
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Methotrexate (Drug)
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Prednisone (Drug)
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Mercaptopurine (Drug)
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Ofatumumab (Biological)
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Vincristine Sulfate (Drug)
Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
干预措施: Rituximab (Biological)
结局指标
主要结局
Event-Free Survival
时间窗: Start of treatment up to 2 years
Event-free survival defined as the time interval from date of treatment start until the date of death, disease progression or relapse.
次要结局
- Overall Survival(Start of treatment up to 2 years)
- Participants to Achieve Complete Remission (CR):(Start of treatment up to 2 years)
- Number of Participants With Minimal Residual Disease (MRD) Negativity(Start of treatment up to 2 years)
- Number of Participants With Adverse Events(Start of treatment up to 30 days after last dose received.)