Clinical trial NCT01769209
Conditions: B-cell Adult Acute Lymphoblastic Leukemia (ALL) Ph-positive Adult Acute Lymphoblastic Leukemia (ALL) Recurrent Adult Acute Lymphoblastic Leukemia (ALL) T-cell Adult Acute Lymphoblastic Leukemia (ALL)
Sponsor: Stanford University
Start date: 2013-03-01; Completion date: 2017-07-04
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates the value of bortezomib in combination with specified chemotherapies for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVE:

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:

* Estimate the rate of complete response (CR) and CR with incomplete platelet recovery (CRp) on Day 29 after re-induction.
* Determine progression-free survival (PFS) at 2 years after re-induction.
* Determine failure-free survival (FFS) at 1 year after re-induction.
* Overall survival (OS) at 1 year after re-induction.
* Assess safety and tolerability of the study drug.
* 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 to 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.

Participants are followed up every 3 months for up to 2 years after completion of study treatment.

Arms: arm 1: Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15.
Interventions: intervention 1: Bortezomib intervention 2: Doxorubicin hydrochloride (HCl) intervention 3: PEG-Asparaginase intervention 4: Vincristine sulfate intervention 5: Dexamethasone intervention 6: Cytarabine intervention 7: Methotrexate
Intervention descriptions: intervention 1: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. intervention 2: Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. intervention 3: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. intervention 4: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. intervention 5: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. intervention 6: Administered intrathecally (IT) at 100 mg, on Day 1 intervention 7: Administered intrathecally (IT) at 15 mg, on Day 15.

Protocol documents: