Clinical Trials / Research Studies

Clinical Trials / Research Studies

Who can participate?

ELIGIBILITY CRITERIA

Inclusion Criteria:

• Age 21 years or younger at the time of initial ALL diagnosis and age > 1 year at the time of study treatment initiation.
• Subjects must have a diagnosis of relapsed or refractory ALL with ≥ 5% blasts in the bone marrow (M2 or M3 disease), with or without extramedullary disease. -To be eligible, subjects must have had 1 or more prior therapeutic attempts, defined as:
  
  • Early first relapse (< 36 months from original diagnosis) after achieving a CR (B-ALL) or first relapse any time following the original diagnosis after achieving a CR (T-ALL)
  • Relapse after achieving a CR following the first or subsequent relapse (i.e., ≥ 2 relapses) OR
  • Failing to achieve a CR from original diagnosis after at least 1 induction attempt
• Subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment before enrollment.
• Subjects must have a serum creatinine level that is ≤ 1.5 × institutional upper limit of normal (ULN) according to age. If serum creatinine level is > 1.5 × ULN, the subject must have a calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m2.
• Adequate liver function, defined as both of the following:
  
  • Total bilirubin ≤ 1.5 × institutional ULN except in the presence of Gilbert Syndrome
  • Alanine aminotransferase (ALT) ≤ 5 × institutional ULN
• Performance status: Karnofsky or Lansky scores ≥ 50 for subjects > 16 years old or ≤ 16 years old, respectively.

Exclusion Criteria:

• Known allergy to any of the drugs used in the study. (Subjects who have had a previous allergy to PEG-asparaginase but can receive Erwinia are eligible.)
• Known allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
• Left ventricular fractional shortening < 30%
• History of ≥ Grade 2 pancreatitis
• Active graft-versus-host disease requiring systemic treatment
• Positive culture for or other clinical evidence of infection with bacteria or fungus within 14 days of the initiation of study treatment
• Down Syndrome
• Prior therapy restrictions:
• Subjects must have completed therapy with granulocyte-colony stimulating factor (G-CSF) or other myeloid growth factors at least 7 days before study treatment initiation, or at least 14 days before study treatment initiation, if pegylated myeloid growth factors were administered.
• Subjects must have completed any type of active immunotherapy (e.g., tumor vaccines) at least 42 days before study treatment initiation.
• At least 3 antibody half-lives must have elapsed since the last dose of monoclonal antibody (e.g., 66 days for rituximab and 69 days for epratuzumab) before subjects may initiate study treatment.
• Subjects must have completed any type of active immunotherapy (e.g., tumor vaccines) at least 42 days before study treatment initiation.
• Subjects must not have received other antineoplastic agents with therapeutic intent, excluding hydroxyurea and antimetabolites administered as part of maintenance chemotherapy, within 7 days prior to study treatment initiation.