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CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Summary
The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.
Official title: A Single-Arm, Open-Label Phase 1b Study of Hyper-CVAD + Calaspargase Pegol in Young Adults With Newly Diagnosed Acute Lymphoblastic Leukemia
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
7
Start Date
2023-05-01
Completion Date
2026-10
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy)
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
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
Rituximab 375mg/m\^2 will be administered once per cycle for patients with CD20+ ALL.
Locations (1)
Moffitt Cancer Center
Tampa, Florida, United States