EUCTR2010-022946-25-Outside-EU/EEA进行中（未招募）不适用
Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 195
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •DISEASE CHARACTERISTICS:
- •Newly diagnosed acute lymphoblastic leukemia (ALL)
- •?Definitive evidence of BCR-ABL fusion (Philadelphia chromosome positive [PH+]) from an approved Children's Oncology Group (COG) cytogenetics laboratory
- •Meets one of the following criteria:
- •?Concurrent enrollment on COG-AALL03B1 (or a successor trial) AND COG-AALL0232, COG-AALL0331, COG-AALL0434 or other front-line COG ALL clinical trial
- •?Concurrent enrollment on COG-AALL03B1 (or a successor trial) AND scheduled to receive a 3 or 4-drug standard induction regimen
- •?Concurrent enrollment on a DFCI Childhood ALL Consortium trial (or scheduled to be treated as per a DFCI Childhood ALL Consortium induction regimen)
- •Received the first 2 weeks of induction therapy prior to study enrollment
- •?Patients may NOT have received day 15 of induction therapy (or day 18 if enrolled on a DFCI Childhood ALL Consortium trial)
- •No Down syndrome
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status (PS) 50-100% (for patients > 16 years of age)
- •Lansky PS 50-100% (for patients = 16 years of age)
- •Creatinine clearance or radioisotope glomerular filtration rate = 70 mL/min OR maximum serum creatinine based on age and gender as follows:
- •?0.4 mg/dL (for patients 1 to 5 months of age)
- •?0.5 mg/dL (for patients 6 to 11 months of age)
- •?0.6 mg/dL (for patients 1 year of age)
- •?0.8 mg/dL (for patients 2 to 5 years of age)
- •?1.0 mg/dL (for patients 6 to 9 years of age)
- •?1.2 mg/dL (for patients 10 to 12 years of age)
- •?1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
- •?1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients = 16 years of age)
- •Total bilirubin = 1.5 times upper limit of normal (ULN)
- •ALT < 2.5 times ULN
- •Shortening fraction = 27% by echocardiogram OR LVEF = 50% by gated radionuclide study
- •QTc = 0.45 seconds by EKG
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No evidence of dyspnea at rest
- •No exercise intolerance
- •Pulse oximetry > 94% at sea level (if there is a clinical indication for determination)
- •Seizure disorder allowed provided it is well controlled on anticonvulsants
- •PRIOR CONCURRENT THERAPY:
- •No other concurrent cancer chemotherapy or immunomodulatory agents (including steroids)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 58
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method.
- •Female patients who are lactating must agree to stop breast-feeding.
- •Patients with Down syndrome
- •Patients with QTc greater than 0.45 seconds. Patients must have an EKG fewer than 6 days prior to enrollment onto AALL0622.
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