Phase II Study of Subcutaneous Bortezomib in Combination With Chemotherapy in Relapsed/Refractory Adult Acute Lymphoblastic Leukemia
PRIMARY OBJECTIVES:
I. Determine the response rate of bortezomib in combination with a chemotherapy backbone of
doxorubicin (doxorubicin hydrochloride), vincristine (vincristine sulfate), PEG-asparaginase
(pegaspargase), and dexamethasone in patients with relapsed/refractory acute lymphoblastic
leukemia.
SECONDARY OBJECTIVES:
I. Determine progression free survival. II. Estimate the rate of complete response (CR) and
CR with incomplete platelet recovery (CRp) after this re-induction compared to a historical
baseline.
III. Estimate failure-free survival (FFS) and survival percent at 1 year compared to a
historical baseline.
IV. Assess safety and tolerability of the study drug. V. Determine whether bortezomib
induces reactive oxygen species (ROS) in circulating acute lymphoblastic leukemia (ALL)
blast cells.
OUTLINE:
Patients receive bortezomib subcutaneously (SC) on days 1, 4, 8, and 11; doxorubicin
hydrochloride intravenously (IV) on day 1; pegaspargase IV or intramuscularly (IM) on days 5
and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) daily on
days 1-14; cytarabine intrathecally (IT) on day 1 and methotrexate intrathecally (IT) on day
15. Patients with central nervous system disease receive intrathecal treatment per
investigator's discretion.
After completion of study treatment, patients are followed up every 3 months for up to 2
years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
CR rate
Response rates will be evaluated and accompanied by 95% confidence intervals using the binomial distribution. Response rate by categories will be calculated with 95% confidence intervals.
On day 29 at the end of induction therapy
No
Michaela Liedtke
Principal Investigator
Stanford University
United States: Federal Government
HEMALL0008
NCT01769209
March 2013
Name | Location |
---|---|
Stanford University | Stanford, California 94305 |