Real World Asparaginase Therapy Toxicity Study
This study aims to understand the short-term and long-term side effects of asparaginase drugs, which are commonly used to treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LLy). Researchers want to see how often patients develop serious side effects (called CTCAE grade 3+ or 4+ toxicities) while receiving standard care therapy or SJALL23T therapy. You may be able to join if you have been diagnosed with ALL, LLy, or mixed phenotype acute leukemia, and are enrolled in the INITIALL study or have recently started post-INITIALL therapy. The study will look at how many people experience these side effects over approximately 2½ to 3 years.
- Study design
- This is an observational study with a planned enrollment of 200 participants. It is not specified if it is randomized or blinded.
- What's involved
- This study involves collecting data about your ALL/LLy, treatment, side effects, and how your leukemia/lymphoma responds to treatment. Blood samples and liver fibroscans (liver ultrasounds) will be taken at different times during your ALL/LLy treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for this study are measured at approximately 2½ to 3 years, indicating a follow-up period of that length.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Real World Asparaginase Therapy Toxicity
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Seth E. Karol, MD, MSCI · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapyApproximately 2½ to 3 years
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.
- Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapyApproximately 2½ to 3 years
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.
- Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SOC therapyApproximately 2½ to 3 years
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.
- Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SJALL23T therapyApproximately 2½ to 3 years
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.
- Probabilities of grade 3+ or 4+ toxicities each phase of SOC treatmentApproximately 2½ to 3 years
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.
- Probabilities of grade 3+ or 4+ toxicities each phase of SJALL23TtreatmentApproximately 2½ to 3 years
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.