A Multi-center Open-label Single-arm Phase 2/3 Trial Evaluating the Safety and Pharmacokinetics of Calaspargase Pegol for Treatment of Adults Aged 22 To >65 Years with Newly-diagnosed Philadelphia-negative ALL | NYU Langone Health

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A Multi-center Open-label Single-arm Phase 2/3 Trial Evaluating the Safety and Pharmacokinetics of Calaspargase Pegol for Treatment of Adults Aged 22 To >65 Years with Newly-diagnosed Philadelphia-negative ALL

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Newly-diagnosed Philadelphia-negative All
Age: Between 22 years - 65 years
Gender: Male or Female

Other Inclusion Criteria:

1) Newly-diagnosed and cytologically confirmed and documented Philadelphia-negative B-cell or T-cell ALL. 2) Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. 3) No prior therapy for ALL such as chemotherapy and radiation therapy before signing the informed consent except for limited treatment (=7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine.

You may not be eligible for this study if the following are true:

1) Patients with Philadelphia chromosome positive ALL, Burkitt’s leukemia, mixed lineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia. 2) Patients with Down syndrome. 3) Participants known to be HIV-positive.