The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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 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.
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGMortality Rate of Hyper-CVAD after first infusion of calaspargase pegol
Mortality rate is hypothesized to be less than 10% when combining calaspargase pegol with Hyper-CVAD.
Time frame: Up to 12 months
Minimal Residual Disease Remission Rate
Minimal Residual Disease (MRD) will be studied as a dichotomous endpoint using a cutoff of 1x10\^4 cells/transcripts as the lower limit for residual leukemia and presented as the percentage of patients reaching this landmark as their best response. MRD assessment will be obtained with each bone marrow biopsy assessment, every 3 months in the first year following their last cycle of therapy and every 6 months in the subsequent 2 years following their last cycle.
Time frame: Up to 3 years
Progression Free Survival
Progression Free Survival defined as the time from start of treatment to the time of progression or death.
Time frame: Up to 42 months
Overall Survival
Overall Survival (OS) will be measured from the initial date of treatment to the recorded date of death.
Time frame: Up to 42 months
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Rituximab 375mg/m\^2 will be administered once per cycle for patients with CD20+ ALL.