Study Results
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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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2026-01-31
2031-07-31
Brief Summary
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Detailed Description
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* 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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Study Design
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COHORT
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
* 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
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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REWASPY
Identifier Type: -
Identifier Source: org_study_id
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