Clinical trial NCT07008027: Real World Asparaginase Therapy Toxicity
Official title: Real World Asparaginase Therapy Toxicity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Drug Toxicity
Keywords: Asparaginase drugs
Toxicity
Acute lymphoblastic leukemia
Acute lymphoblastic lymphoma
Mixed phenotype acute leukemia
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants meeting the Eligibility Criteria.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapy
timeFrame: Approximately 2½ to 3 years
measure: Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapy
timeFrame: Approximately 2½ to 3 years
measure: Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SOC therapy
timeFrame: Approximately 2½ to 3 years
measure: Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SJALL23T therapy
timeFrame: Approximately 2½ to 3 years
measure: Probabilities of grade 3+ or 4+ toxicities each phase of SOC treatment
timeFrame: Approximately 2½ to 3 years
measure: Probabilities of grade 3+ or 4+ toxicities each phase of SJALL23Ttreatment
timeFrame: Approximately 2½ to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Seth E. Karol, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References: