Philadelphia chromosome-positive acute lymphoblastic leukemia
Conditions
Interventions
Group A:Nilotinib plus multi-agent chemotherapy
Sponsors
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 61 Years
Inclusion criteria
Inclusion criteria: (1) Patients aged 18 to 60 years with De novo Philadelphia chromosome positive (Philadelphia chromosome positive or BCR/ABL transcript positive) acute lymphoblastic leukemia; (2) ECOG Performance status ?2; (3) Adequate end organ function as defined by: Total bilirubin 45 % on MUGA scan); (4) Patients must have the following laboratory values (>= LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication.): Potassium >= LLN; Magnesium >= LLN; Phosphorus >= LLN(5)Patients should sign informed consent form.
Exclusion criteria
Exclusion criteria: (1)Impaired cardiac function: Long QT syndrome or a known family history of long QT syndrome; clinically significant resting brachycardia ( 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 12 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias); (2) Other concurrent severe and/or uncontrolled medical conditions: Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease; (3) Patients who are pregnant or breast feeding; (4) Who is known human deficiency virus (HIV) positive; (5) The capsules contain lactose, and Nilotinib is therefore not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption; (6) Use of any other investigational agent in the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remissio; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactJianxiang Wang
Outcome results
None listed