An observational study in Drug Toxicity, sponsored by St. Jude Children's Research Hospital. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by St. Jude Children's Research Hospital · Observational
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
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.
449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
This study's planned enrollment of 200 is below the median of 414 across 162 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.
Browse Drug-Related Side Effects and Adverse Reactions studies →St. Jude Children's Research Hospital is the lead sponsor of 440 studies on the registry; 102 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants meeting the Eligibility Criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Post-INITIALL therapy is:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receiving non -protocol standard if care (SOC) treatment.
Participants receiving protocol therapy on SJALL23T and not receiving investigational drug.
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapy
The overall probability of on-therapy grade 3+ or 4+ toxicity will be estimated by the sample proportion along with the Normal approximation (Z-statistic) based 95% confidence interval.
Time frame: Approximately 2½ to 3 years
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapy
The overall probability of on-therapy grade 3+ or 4+ toxicity will be estimated by the sample proportion along with the Normal approximation (Z-statistic) based 95% confidence interval.
Time frame: Approximately 2½ to 3 years
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SOC therapy
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.
Time frame: Approximately 2½ to 3 years
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SJALL23T therapy
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.
Time frame: Approximately 2½ to 3 years
Probabilities of grade 3+ or 4+ toxicities each phase of SOC treatment
Probabilities of grade 3+ or 4+ toxicities will be estimated for each treatment phase by sample proportions accompanied by the Z-statistic 95% confidence intervals.
Time frame: Approximately 2½ to 3 years
Probabilities of grade 3+ or 4+ toxicities each phase of SJALL23Ttreatment
Probabilities of grade 3+ or 4+ toxicities will be estimated for each treatment phase by sample proportions accompanied by the Z-statistic 95% confidence intervals.
Time frame: Approximately 2½ to 3 years
Start is estimated for Nov 2026; primary completion for Jul 2030, 44 months later.
Of 65 non-industry observational studies under Drug-Related Side Effects and Adverse Reactions, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24. This study's planned 44 months is below that.
Counting every sponsor, half of 69 studies reached it within 45 months; a quarter within 24 and three quarters within 97.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 22, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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