Vanderbilt-Ingram Cancer Center

The purpose of this study is to find out what effects, good and/or bad, the investigational drug dasatinib has on leukemia. Dasatinib is approved for use in the treatment of chronic myeloid leukemia and resistant Philadelphia chromosome positive ALL (two sub-types of leukemia) but is investigational as it is used on this study. We would like to determine what the effects of dasatinib in combination with drugs that are usually given as standard care will have with or without a stem cell transplant.

Criteria
 Inclusion Criteria:

 • Morphologic diagnosis of acute lymphoblastic leukemia (ALL) with evidence of involvement in bone marrow and/or blood

 • No extramedullary disease in the absence of bone marrow or blood involvement

 • Philadelphia chromosome (Ph)- and/or BCR/ABL-positive as confirmed by standard cytogenetics, FISH, and/or PCR

 • No minimally differentiated acute myeloid leukemia (M0), mixed lineage leukemia, or L3 (Burkitt) ALL

 • Lineage (B-cell, T-cell, or mixed B/T cell) must be determined

 • Appropriate marker studies, including CD19 (B-cell), CD10, CD5, and CD7 (T-cell) must be performed

 • Co-expression of myeloid antigens (CD13 and CD33) allowed

 • Must be enrolled on clinical trials SWOG-9007, and ECOG-E3903 or CALGB-8461 (for ECOG and CALGB sites)

 • Patients may have received no more than one course of remission induction therapy for ALL; patients who have received any post-remission therapy for ALL or who have relapsed from complete remission are not eligible; (patients with previously untreated ALL can be eligible, and patients who have received one course of remission induction therapy for ALL can be eligible, regardless of their response to therapy); patients may have received no more than 14 days of tyrosine kinase inhibitor therapy prior to registration; any prior induction chemotherapy must have been completed no more than 28 days prior to registration

 • NOTE: If the patient has been initiated on the protocol defined regimen (i.e. the hyperCVAD regimen without a Tyrosine kinase inhibitor) before the Ph/BCR-ABL status was known, the patient may be registered on the protocol and start dasatinib; in this first course, dasatinib will be administered up to Day 14 (i.e. if the patient is registered on Day 5 and starts therapy on Day 6, only 8 days of dasatinib will be administered and dasatinib will be completed on Day 14)

 • No active pericardial effusion, ascites, or pleural effusion of any grade

 • Available matched donor meeting the following criteria:

 • Completely matched (i.e., HLA-A, -B, DRβ1) sibling donor OR 10/10-matched non-sibling donor

 • Must not be monozygotic identical twin of patient

 • Zubrod performance status 0-2

 • Bilirubin ≤ 3.0 times upper limit of normal (ULN)

 • AST and/or ALT ≤ 3.0 times ULN

 • Serum creatinine ≤ 3.0 times ULN

 • Patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

 • HIV-positive patients allowed except in transplantation portion of the study

 • No prolonged QTc interval (QTc > 480 msec)

 • No other prior malignancy except for any of the following:

 • Adequately treated basal cell or squamous cell skin cancer

 • In situ cervical cancer

 • Adequately treated stage I or II cancer from which the patient is currently in complete remission

 • Any other cancer from which the patient has been disease-free for 5 years

 • No known history of type I hypersensitivity or anaphylactic reactions to doxorubicin

 • More than 28 days since prior induction chemotherapy

 • Collection and submission of pre-treatment cytogenetic specimens must be completed within 28 days prior to registration on S0805