Status:
TERMINATED
Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Lead Sponsor:
Rony Schaffel
Conditions:
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Patients with acute lymphoblastic leukemia and positivity for the breakpoint cluster region-Abelson murine leukemia (BCR-ABL) protein or the Philadelphia chromosome have a poor prognosis with standard...
Eligibility Criteria
Inclusion
- Diagnosis of Acute Lymphoblastic Leukemia (ALL)
- BCR-ABL positive positive by PCR (central Lab)
- No previous treatment for ALL except for corticoids and cyclophosphamide less than 600 mg/m2
- Must be able to swallow tablets
- Lab results within normal limits (Potassium, Calcium, Magnesio, Phosphorus, Transaminases, Alkaline Phosphatase, Bilirrubine, Amylase, Lypase)
Exclusion
- Heart disease
- Interval QTc Fridericia \> 480 msec
- Coumadin use
- Pregnancy
- PS = 4
- Previous medical history of etilism or/and pancreatic disease
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00905398
Start Date
May 1 2009
End Date
July 1 2015
Last Update
July 9 2015
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