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Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Not Recruiting
Trial ID: NCT01256398
Purpose
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.
Official Title
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
Stanford Investigator(s)
Michaela Liedtke
Professor of Medicine (Hematology)
Eligibility
Inclusion Criteria:
* 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)
Intervention(s):
biological: alemtuzumab
other: pharmacological study
procedure: in vitro-treated peripheral blood stem cell transplantation
biological: filgrastim
biological: pegfilgrastim
drug: tacrolimus
drug: cyclophosphamide
drug: cytarabine
drug: dasatinib
drug: daunorubicin hydrochloride
drug: Dexamethasone
drug: etoposide phosphate
drug: fludarabine phosphate
drug: leucovorin calcium
drug: melphalan
drug: methotrexate
procedure: allogeneic hematopoietic stem cell transplantation
procedure: autologous hematopoietic stem cell transplantation
drug: vincristine sulfate
other: laboratory biomarker analysis
drug: mercaptopurine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061