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About
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.
Full 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.
Enrollment
Sex
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Inclusion and exclusion criteria
INCLUSION CRITERIA
Voluntary written informed consent
Female subjects who:
Male subjects, even if surgically sterilized (ie, status post vasectomy) who:
• Relapsed or refractory B or T cell acute lymphoblastic leukemia that has progressed following at least one prior therapy. Ph+ patients are eligible. Relapsed ALL is defined in patients as the reappearance of leukemia cells in the peripheral blood or bone marrow or appearance of extramedullary disease after a complete remission. Refractory ALL is defined in patients as failure to achieve a complete remission after induction therapy. Complete remission is defined by <5% leukemia cells in the bone marrow with recovery of peripheral blood counts. Relapsed disease can be documented by bone marrow biopsy (>5% cells in the bone marrow) or by flow cytometry in the peripheral blood or biopsy of extramedullary disease.
Has received at least 1 line of prior systemic therapy that may NOT have included bortezomib (Velcade); patients who have undergone autologous/allogeneic stem cell transplantation are eligible
Transplant-eligible patients are eligible
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
No poorly-controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, or psychiatric illness that in the opinion of the investigator would limit compliance with study requirements
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 x (ULN unless elevation is deemed due to leukemia infiltration)
Adequate renal function defined as creatinine clearance of ≥ 30 mL/minute by the Cockcroft-Gault method
EXCLUSION CRITERIA
Primary purpose
Allocation
Interventional model
Masking
18 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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