A Phase II/III Study of Calaspargase Pegol for Adults with Newly Diagnosed Philadelphia-negative Acute Lymphoblastic Leukemia


Full Title

A Multicenter, 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


Standard treatments for adults with newly diagnosed acute lymphoblastic leukemia (ALL) include a combination of different chemotherapy drugs that are routinely used to treat ALL in children. Researchers think that adding the drug calaspargase pegol to these chemotherapy drugs may be an effective treatment for adults. Calaspargase pegol is used in the treatment of ALL in people age 21 and younger; its use in this study is investigational.

The purpose of this study is to find the highest dose of calaspargase pegol that can be given with combination chemotherapy in adults with ALL that is negative for a genetic mutation called the Philadelphia chromosome. Calaspargase pegol is designed to block asparagine, an enzyme that helps cancer cells survive. It also helps kill cancer cells in places where chemotherapy drugs have a hard time reaching, like the brain and spinal cord.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have previously untreated ALL that does not contain the Philadelphia chromosome.
  • This study is for people age 22 and older.


For more information about this study and to inquire about eligibility, please contact the office of Dr. Jae Park at 646-608-3743.





Disease Status

Newly Diagnosed



ClinicalTrials.gov ID