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TACL-CFZ008 - Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Patients must have relapsed or refractory Acute Lymphoblastic Leukemia (ALL).
The purpose of the study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).
- Ages eligible for study: Child, Adult.
- Age 21 years or younger at the time of initial ALL diagnosis and age > 1 year at the time of study treatment initiation.
- Patients 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.
- Patients must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment before enrollment.
- Patients 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, or for children<2 years of age, ≥ 50mL/min/1.73 m2.
- Adequate liver function,
- Performance status: Karnofsky or Lansky scores ≥ 50 for subjects > 16 years old or ≤ 16 years old, respectively.
Detailed inclusion and exclusion criteria as listed on clinicaltrials.gov.
Eric S. Schafer, MD, MHS
Local Principal Investigator
Texas Children’s Cancer and Hematology Center