NCT01312818 - Bortezomib, Vorinostat and Dexamethasone for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions

Acute Lymphoblastic Leukemia

Interventions

DRUG

Bortezomib

1.3 mg/m\^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.

DRUG

Vorinostat

180 mg/m\^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14

DRUG

Dexamethasone

6 mg/m\^2 by mouth (PO) divided twice a day (BID) on days 4-15.

DRUG

Methotrexate

Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)

DRUG

Imatinib mesylate

"For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for \>18 years on Days 1-16."

Trial Locations (1)

55455

Masonic Cancer Center, University if Minnesota, Minneapolis