Real World Asparaginase Therapy Toxicity

Not yet recruiting

• Conditions: Drug Toxicity

• Registration Number: NCT07008027
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-28
• Study First Posted: 2025-06-06
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-30
• Last Update Posted: 2025-10-31
• Study Start: 2025-11-01
• Primary Completion: 2030-07
• Study Completion: 2031-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapy	Approximately 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 therapy	Approximately 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 therapy	Approximately 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 therapy	Approximately 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 treatment	Approximately 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 SJALL23Ttreatment	Approximately 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.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States