Status and phase
Conditions
Treatments
About
The purpose of this phase 2/3 study is to confirm the recommended doses and to evaluate the safety and pharmacodynamics of Calaspargase pegol for the treatment of adult patients with Philadelphia-negative Acute Lymphoblastic Leukemia.
Full description
The study will be conducted in 2 parts. Part 1 is a dose confirmation run-in period. Part 2 will enroll the remaining participants at the dose as confirmed in Part 1.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
122 participants in 1 patient group
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Central trial contact
Institut de Recherches Internationales Servier, Clinical Studies Department
Data sourced from clinicaltrials.gov
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