Real World Asparaginase Therapy Toxicity (NCT07008027) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Real World Asparaginase Therapy Toxicity
United States200 participantsStarted 2026-06
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapy
Timeframe: Approximately 2½ to 3 years
3
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SOC therapy
Timeframe: Approximately 2½ to 3 years
4
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SJALL23T therapy
Timeframe: Approximately 2½ to 3 years
5
Probabilities of grade 3+ or 4+ toxicities each phase of SOC treatment
Timeframe: Approximately 2½ to 3 years
6
Probabilities of grade 3+ or 4+ toxicities each phase of SJALL23Ttreatment