Real World Asparaginase Therapy Toxicity

Real World Asparaginase Therapy Toxicity

This research study is being done to learn more about the short term and long term side effects of treatment with asparaginase drugs, which are commonly used in acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma (LLy) therapy.

Primary Objective

• To estimate the rate of high-grade toxicities which occur during therapy for acute lymphoblastic leukemia/ lymphoma in patients receiving asparaginase-containing standard of care therapy.

This study will involve the collection of data about the participants ALL/LLy, treatment, side effects of treatment and leukemia/ lymphoma's response to treatment. Data collected on other research studies participants are enrolled on will also be used for this research study.

Blood samples will be collected and liver fibroscans (liver ultrasounds) will be done at different time points while the participant is receiving treatment for ALL/LLy. The time points will depend on what treatment they receive and will correspond to days on their treatment roadmap.

Inclusion Criteria:

• Diagnosis of acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia

• Enrolled on INITIALL and no more than 10 days after initiation of post-INITIALL therapy

• Post-INITIALL therapy is:

  • Standard of Care (SOC)/Non Protocol Treatment Plan (NPTP) as per Total therapy or
  • SJALL23T and not scheduled to receive venetoclax

Exclusion Criteria:

• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.