Real World Asparaginase Therapy Toxicity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Drug Toxicity. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- 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]
- Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapy [Time frame: Approximately 2½ to 3 years]
- 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 SJALL23T therapy [Time frame: Approximately 2½ to 3 years]
- 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 each phase of SJALL23Ttreatment [Time frame: Approximately 2½ to 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- St. Jude Children's Research Hospital — Memphis
Identifiers
NCT: NCT07008027 · REWASPY