Real World Asparaginase Therapy Toxicity

Part of paid clinical trials in Memphis, Tennessee.

Sponsor: St. Jude Children's Research Hospital
Study ID: NCT07008027
Status: Not Yet Recruiting

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Conditions

Drug Toxicity

Eligibility Criteria

Sex: ALL
Age: N/A - N/A
Healthy Volunteers: Not accepted

Study Details

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.

Key Dates

Start date: Jun 30, 2026
Status verified: May 2026
Primary completion: Jul 31, 2030
Completion: Jul 31, 2031

Study Design

Enrollment: 200 participants (estimated)

Arms

Arm: Non-protocol therapy /standard of care therapy
Participants receiving non -protocol standard if care (SOC) treatment.
Arm: SJALL23T (NCT06390319) protocol therapy
Participants receiving protocol therapy on SJALL23T and not receiving investigational drug.

Primary Outcome Measure

Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapy [ Time Frame: Approximately 2½ to 3 years ]

Central Contacts

Seth E. Karol, MD, MSCI
888-226-4343
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
St. Jude Children's Research Hospital	Memphis	Tennessee	38105	Seth E. Karol [email protected] 888-226-4343 Seth E. Karol, MD, MSCI (PRINCIPAL_INVESTIGATOR)

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St. Jude Children's Research Hospital· Memphis, TN