Gene Therapy Clinical Trials
Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
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
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)
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting