Drug Toxicity
Conditions
Keywords
Asparaginase drugs, Toxicity, Acute lymphoblastic leukemia, Acute lymphoblastic lymphoma, Mixed phenotype acute leukemia
Brief 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.
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.
Interventions
None listed
Sponsors
St. Jude Children's Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapy | Approximately 2½ to 3 years | 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. |
| Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapy | Approximately 2½ to 3 years | 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. |
| Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SOC therapy | Approximately 2½ to 3 years | Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method. |
| Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SJALL23T therapy | Approximately 2½ to 3 years | Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method. |
| Probabilities of grade 3+ or 4+ toxicities each phase of SOC treatment | Approximately 2½ to 3 years | Probabilities of grade 3+ or 4+ toxicities will be estimated for each treatment phase by sample proportions accompanied by the Z-statistic 95% confidence intervals. |
| Probabilities of grade 3+ or 4+ toxicities each phase of SJALL23Ttreatment | Approximately 2½ to 3 years | Probabilities of grade 3+ or 4+ toxicities will be estimated for each treatment phase by sample proportions accompanied by the Z-statistic 95% confidence intervals. |
Countries
United States
Contacts
CONTACTSeth E. Karol, MD, MSCI
PRINCIPAL_INVESTIGATORSeth E. Karol, MD, MSCI
St. Jude Children's Research Hospital
Outcome results
None listed