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Real World Asparaginase Therapy Toxicity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at short-term and long-term side effects of asparaginase drugs. These drugs are often used to treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LLy). The study is for people with certain blood cancers who were enrolled in INITIALL and meet the treatment rules.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia. These are types of blood cancer.
  • Be enrolled in INITIALL, with no more than 10 days since starting treatment after INITIALL.
  • After INITIALL, receive either standard care or a non-study treatment plan based on Total therapy, or receive SJALL23T treatment with no plans to receive venetoclax.

Who can't join

  • You or your legal guardian or representative cannot or do not want to give written consent to join the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TN