A Therapeutic Trial of Decitabine (Dacogen) and Vorinostat (SAHA) in Combination With Chemotherapy (Vincristine, Prednisone, Doxorubicin and PEG-Asparaginase) for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) MT2008-29R
- Patients undergo blood and bone marrow sample collection at baseline, on day 5, Day 19
and at the end of study treatment for correlative laboratory studies. Samples are
analyzed for hypermethylation at diagnosis and demethylation post-exposure with
decitabine and vorinostat using LINE methylation.
Patients receive decitabine IV over 1 hour and oral vorinostat twice daily on days 1-4;
vincristine sulfate IV on days 5, 12, 19, and 26; oral prednisone twice daily on days 5-33;
doxorubicin hydrochloride IV over 15 minutes and cytarabine intrathecally (IT) on day 5;
pegaspargase IV or intramuscularly on days 6, 12, 19, and 26; and methotrexate* IT on days
12 and 33. Patients with Philadelphia chromosome-positive disease may also receive oral
imatinib mesylate once daily on days 5-33.
NOTE: *Patients with central nervous system (CNS)-positive disease also receive methotrexate
IT on days 19 and 26.
Patients undergo blood and bone marrow sample collection at baseline, on day 5, Day 19 and
at the end of study treatment for correlative laboratory studies.
After completion of study treatment, patients are followed for 60 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response to Treatment
as measured by remission rate at day 33 (< 5% blasts) or day 42 per RECIST criteria
Day 33 or Day 42
Michael J. Burke, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|University of Minnesota Amplatz Children's Hospital||Minneapolis, Minnesota 55455|