CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Conditions

Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy) — DRUG
Hyper-CVAD consists of two combinations of drugs (courses A and B) given in an alternating fashion. The term "hyper" refers to the hyperfractionated nature of the chemotherapy, which is given in small doses, more frequently, to minimize side effects. CVAD is the acronym of the drugs in course a: cyclophosphamide, vincristine, doxorubicin and dexamethasone. Course A: Cyclophosphamide days 1, 2 and 3. Vincristine days 4 and 11, Doxorubicin day 4, dexamethasone days 1-4 and 11-14, Cytarabine day 7. Mesna is also given orally with cyclophosphamide, to reduce the incidence of haemorrhagic cystitis, a common side effect of cyclophosphamide. Methotrexate, an antimetabolite, may be given when necessary to get chemotherapy past the blood brain barrier. Course B: Methotrexate Day 1 and Cytarabine Days 2 and 3. Dosage is individualized to the patient.
Calaspargase Pegol — DRUG
Calaspargase pegol 2000 IU/m\^2 (capped at 3750 IU) will be administered beginning in cycle 1B of Hyper-CVAD, and will continue at this dose for the duration of the trial.
Rituximab — DRUG
Rituximab 375mg/m\^2 will be administered once per cycle for patients with CD20+ ALL.

The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.

Experimental: Hyper-CVAD + Calaspargase pegol Treatment
Participants will receive calaspargase pegol administered over 1 hour with each cycle of Hyper-CVAD, mini-CVD, and late intensification, beginning with Cycle 1B. Responding patients will have dose reduction of HyperCVAD for Cycles 2B-4B. Participants with CD20+ ALL will also be given Rituximab once per cycle.

Mortality Rate of Hyper-CVAD after first infusion of calaspargase pegol [ Time Frame: Up to 12 months ]

Facility	City	State	ZIP	Site coordinators
Moffitt Cancer Center	Tampa	Florida	33612	Hannah Lewis [email protected] 813-745-8650 Bijal Shah, MD (PRINCIPAL_INVESTIGATOR) Julio Chavez, MD, MS (SUB_INVESTIGATOR) Sameh Gaballa, MD (SUB_INVESTIGATOR) Leidy Isenalumhe, MD, MS (SUB_INVESTIGATOR) Hayder Saeed, MD (SUB_INVESTIGATOR) Lubomir Sokol, MD, PhD (SUB_INVESTIGATOR)

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