Real World Asparaginase Therapy Toxicity

NCT ID: NCT07008027

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2031-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Drug Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-protocol therapy /standard of care therapy

Participants receiving non -protocol standard if care (SOC) treatment.

No interventions assigned to this group

SJALL23T (NCT06390319) protocol therapy

Participants receiving protocol therapy on SJALL23T and not receiving investigational drug.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seth E. Karol, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Central Contacts

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Seth E. Karol, MD, MSCI

Role: CONTACT

866-278-5833

Facility Contacts

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Seth E. Karol

Role: primary

866-278-5833

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

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REWASPY

Identifier Type: -

Identifier Source: org_study_id

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