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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.
Primary Objective
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-protocol therapy /standard of care therapy | Participants receiving non -protocol standard if care (SOC) treatment. | ||
| SJALL23T (NCT06390319) protocol therapy | Participants receiving protocol therapy on SJALL23T and not receiving investigational drug. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 2½ to 3 years |
| 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. | Approximately 2½ to 3 years |
| 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. | Approximately 2½ to 3 years |
| 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. | Approximately 2½ to 3 years |
| Probabilities of grade 3+ or 4+ toxicities each phase of SOC treatment | 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. | Approximately 2½ to 3 years |
| Probabilities of grade 3+ or 4+ toxicities each phase of SJALL23Ttreatment |
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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:
Exclusion Criteria:
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Participants meeting the Eligibility Criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seth E. Karol, MD, MSCI | Contact | 888-226-4343 | referralinfo@stjude.org |
| Name | Affiliation | Role |
|---|---|---|
| Seth E. Karol, MD, MSCI | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015456 | Leukemia, Biphenotypic, Acute |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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Blood
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.
| Approximately 2½ to 3 years |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |