A Study of RC-P as a Treatment for People with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Who Are Allergic to PEG-Asparaginase

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Full Title

An Open-Label, Multicenter Study of RC-P in Patients with Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) Following Hypersensitivity to E. coli-derived Asparaginases

Purpose

PEG-asparaginase is a medication used in the standard treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). However, some patients have an allergic reaction to PEG-asparaginase.

In this study, researchers are assessing a different form of asparaginase, called RC-P, in place of PEG-asparaginase in patients with ALL or LBL who are allergic to PEG-asparaginase. They would like to find the highest dose that can be given safely as well as examine its effectiveness in these patients. They will evaluate two ways of giving the drug: intramuscular injection (a needle inserted into the muscle to give a shot of medicine) and intravenous infusion (into a vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have ALL or LBL and have experienced an allergic reaction to PEG-asparaginase.
  • Patients may not have relapsed disease.
  • This study is for patients of all ages (children and adults).

For more information about this study and to inquire about eligibility, please contact Dr. Christopher Forlenza at 212-639-5226.

Protocol

20-182

Phase

II/III

Disease Status

Newly Diagnosed

Co-Investigators