Clinical trial · Observational
Real World Asparaginase Therapy Toxicity
NCT07008027CI-TRIAL-00121844not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Non-protocol therapy /standard of care therapy
- description
- Participants receiving non -protocol standard if care (SOC) treatment.
- label
- SJALL23T (NCT06390319) protocol therapy
- description
- Participants receiving protocol therapy on SJALL23T and not receiving investigational drug.
Primary outcomes (6)
- 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
- description
- 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.
- measure
- Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.