Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone and bortezomib, 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.
详细描述
PRIMARY OBJECTIVE:
I. To collect the safety/toxicity information and assess the initial efficacy information (objective overall response rate: complete response [CR]+ CR with incomplete platelet recovery [CRp]/CR with incomplete bone marrow recovery [CRi]) after treatment with clofarabine, etoposide, cyclophosphamide (CEC), vincristine sulfate liposome (liposomal vincristine) (VCR), dexamethasone and bortezomib in relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) including relapsed/refractory Philadelphia (Ph) positive B-ALL/LL or Burkitt's leukemia/lymphoma or double-hit leukemia/lymphoma.
SECONDARY OBJECTIVE:
I. To determine the CR duration, event free survival (EFS), and overall survival (OS) after treatment with CEC, liposomal VCR, dexamethasone and bortezomib in relapsed/refractory ALL or LL including relapsed/refractory Ph positive B-ALL/LL or Burkitt's leukemia/lymphoma or double-hit leukemia/lymphoma.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL):
- •Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II)
- •Relapsed and/or refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia/lymphoma or "double-hit" leukemia/lymphoma (phase II only)
- •At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset
- •Age older than 15 years
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (There may be certain patients with performance status [PS] 3 in the context of rapidly proliferative/refractory ALL who would benefit from this regimen. We don't want to exclude such patients who may derive benefit from this salvage regimen)
- •Serum bilirubin =< 1.5 mg/dL
- •Serum glutamate pyruvate transaminase (SGPT) =< 3 x upper limit normal (ULN), with exception for Gilbert's syndrome
- •Estimated creatinine clearance or GFR (glomerular filtration rate) >= 50 mL/min
- •Signed informed consent
排除标准
- •Active >= grade 3 peripheral neuropathy
- •Active hepatic graft-versus-host disease
- •Known positivity for hepatitis B or C
- •Pregnancy
- •Breast feeding
研究组 & 干预措施
Treatment (combination chemotherapy)
See detailed description
干预措施: Etoposide (Drug)
Treatment (combination chemotherapy)
See detailed description
干预措施: Ofatumumab (Biological)
Treatment (combination chemotherapy)
See detailed description
干预措施: Pegfilgrastim (Biological)
Treatment (combination chemotherapy)
See detailed description
干预措施: Cyclophosphamide (Drug)
Treatment (combination chemotherapy)
See detailed description
干预措施: Vincristine Sulfate Liposome (Drug)
Treatment (combination chemotherapy)
See detailed description
干预措施: Rituximab (Biological)
Treatment (combination chemotherapy)
See detailed description
干预措施: Bortezomib (Drug)
Treatment (combination chemotherapy)
See detailed description
干预措施: Clofarabine (Drug)
Treatment (combination chemotherapy)
See detailed description
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 8 years
The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events.
Overall response rate (ORR) (Phase II)
时间窗: Up to 8 years
Will be estimated along with the exact 95% confidence interval.
次要结局
- Overall survival(From initiation of treatment, assessed up to 8 years)
- Event free survival(From the treatment start, assessed up to 8 years)