NCT07008027

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
60mo left

Started Aug 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

3.9 years

First QC Date

May 28, 2025

Last Update Submit

July 27, 2026

Conditions

Drug Toxicity

Keywords

Asparaginase drugsToxicityAcute lymphoblastic leukemiaAcute lymphoblastic lymphomaMixed phenotype acute leukemia

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Approximately 2½ to 3 years

Study Arms (2)

Non-protocol therapy /standard of care therapy

Participants receiving non -protocol standard if care (SOC) treatment.

SJALL23T (NCT06390319) protocol therapy

Participants receiving protocol therapy on SJALL23T and not receiving investigational drug.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants meeting the Eligibility Criteria.

You may qualify if:

  • 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

You may not qualify if:

  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Biphenotypic, Acute

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Seth E. Karol, MD, MSCI

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seth E. Karol, MD, MSCI

CONTACT

888-226-4343referralinfo@stjude.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 6, 2025

Study Start

August 1, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2031

Last Updated

July 29, 2026

Record last verified: 2026-07

Locations

US(1)