Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Not Recruiting

Trial ID: NCT01256398

Age - 18 Years-N/A Condition - Blood and Marrow Transplant (BMT), Leukemia, Acute Lymphoid leukemia (ALL) Gender - All Accepting Healthy Volunteers - No

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
Michaela Liedtke

Associate 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)

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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

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