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NCT Number: NCT07008027

Real World Asparaginase Therapy Toxicity

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.

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Key information

Conditions

Drug Toxicity Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Biphenotypic, Acute Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location contact

Seth E. Karol

CONTACT

[email protected]

888-226-4343

Seth E. Karol, MD, MSCI

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    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.

  2. Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapy

    Time frame: 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.

  3. Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SOC therapy

    Time frame: 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.

  4. Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SJALL23T therapy

    Time frame: 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.

  5. Probabilities of grade 3+ or 4+ toxicities each phase of SOC treatment

    Time frame: 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.

  6. Probabilities of grade 3+ or 4+ toxicities each phase of SJALL23Ttreatment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Seth E. Karol, MD, MSCI

CONTACT

[email protected]

888-226-4343

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jun 6, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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