Real World Asparaginase Therapy Toxicity
ConditionDrug Toxicity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSt. Jude Children's Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Standard of Care (SOC)/Non Protocol Treatment Plan (NPTP) as per Total therapy or
SJALL23T and not scheduled to receive venetoclax
Disqualifiers
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Trial population
Participants meeting the Eligibility Criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Non-protocol therapy /standard of care therapy
Group B: SJALL23T (NCT06390319) protocol therapy
Trial outcomes
Primary outcomes
1
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapy
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.
Time frame
Approximately 2½ to 3 years2
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapy
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.
Time frame
Approximately 2½ to 3 years3
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SOC therapy
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.
Time frame
Approximately 2½ to 3 years4
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SJALL23T therapy
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.
Time frame
Approximately 2½ to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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