A Phase II Study of Dasatinib (Sprycel®) (NSC #732517) as Primary Therapy Followed by Transplantation for Adults >/= 18 Years With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by CALGB, ECOG and SWOG
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 101
- 主要终点
- Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause
研究概览
简要总结
This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.
详细描述
PRIMARY OBJECTIVES:
I. Estimate the disease-free survival (DFS) and overall survival (OS) profiles in newly diagnosed patients 18 years or older who have Philadelphia chromosome positive (Ph+) (BCR/(v-abl Abelson murine leukemia viral oncogene homolog [ABL]+) acute lymphoblastic leukemia (ALL) receiving sequential dasatinib followed by allogeneic or autologous hematopoietic cell transplant (HCT) or chemotherapy followed by dasatinib maintenance.
SECONDARY OBJECTIVES:
I. Compare the OS and DFS profiles for each of the three cohorts to those from similar populations from other studies.
II. Determine the ability of dasatinib to produce or maintain a BCR/ABL-negative status, as judged by quantitative-polymerase chain reaction (Q-PCR) following sequential dasatinib, chemotherapy, and HCT.
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
- •Unequivocal histologic diagnosis of ALL
- •Detection of the t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics or BCR-ABL positive status by molecular analysis (Q-PCR or fluorescent in situ hybridization [FISH]) in a Cruise Lines International Association (CLIA)-approved laboratory
- •No prior therapy except up to one week of corticosteroids and/or hydroxyurea to enable time for the detection of t(9;22)(q34;q11) or BCR/ABL
- •Non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control and contraception should continue for three months after the last dose of dasatinib to allow complete clearance of drug and its principal metabolites from the body; in women of childbearing potential, a pregnancy test will be required at study entry
- •Left ventricular ejection fraction >= lower limit of institutional normal
- •No myocardial infarction within 6 months
- •No ventricular tachyarrhythmia within 6 months
- •No major conduction abnormality (unless a cardiac pacemaker is present)
排除标准
- 未提供
研究组 & 干预措施
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Alemtuzumab (Biological)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Autologous Hematopoietic Stem Cell Transplantation (Procedure)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Cyclophosphamide (Drug)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Cytarabine (Drug)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Dasatinib (Drug)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Daunorubicin Hydrochloride (Drug)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Dexamethasone (Drug)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Etoposide Phosphate (Drug)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Filgrastim (Biological)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Fludarabine Phosphate (Drug)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: In Vitro-Treated Peripheral Blood Stem Cell Transplantation (Procedure)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Leucovorin Calcium (Drug)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Melphalan (Drug)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Mercaptopurine (Drug)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Methotrexate (Drug)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Pegfilgrastim (Biological)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Pharmacological Study (Other)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Tacrolimus (Drug)
Treatment (chemotherapy, transplant)
See Detailed Description
干预措施: Vincristine Sulfate (Drug)
结局指标
主要结局
Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause
时间窗: At 3 years after CR
Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.
次要结局
- Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR)(10 years)
- Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring.(10 years)
- Overall Survival (OS)(10 years)
- Disease Free Survival (DFS)(10 years)
- Response(10 years)