Real World Asparaginase Therapy Toxicity

St. Jude Children's Research Hospital

Status

Not yet enrolling

Conditions

Drug Toxicity

Study type

Observational

Funder types

Other

Identifiers

NCT07008027

REWASPY

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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