Induction Therapy With Cytarabine, High-Dose Mitoxantrone and Dasatinib for Patients With Philadelphia-Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia

PHASE1CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
LeukemiaAcute Lymphoblastic Leukemia
Interventions
DRUG

Dasatinib, Mitoxantrone, Cytarabine

"INDUCTION- Dasatinib† (dose levels 1-3) \*continuously Cytarabine 3 g/m2 IV over 3 hours Mitoxantrone 80 mg/m2 IV Myeloid growth factor on day 7 until ANC \> 1,000/μl x 2 days Allopurinol 300 mg BID-TID x 7 days (starting 6-12 hours prior to chemotherapy) Dexamethasone 0.1% eye drops q6h while on cytarabine (start prior to the first dose of cytarabine and continuing at least 24 hours after the last dose) IT Methotrexate 12 mg days 2 and 4~CONSOLIDATION A-Dasatinib† (dose levels 1-3) \*continuously Vincristine 2 mg IV Dexamethasone 10 mg/m2/d days 2 to 29, then taper over 10 days Sulfamethoxazole/Trimethoprim 1 DS BID three times weekly days 2 to 29, then BID daily days 30 to 45 IT Methotrexate 12 mg days 8, 15, 22 and 29"

Trial Locations (1)

10065

Memorial Sloan-Kettering Cancer Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER