RECRUITING

Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

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Conditions

T-cell Acute Lymphoblastic LeukemiaT-cell LymphomaMixed Phenotype Acute LeukemiaNewly DiagnosedChildrenYoung AdultsMixed Phenotype Acute Leukemia (MPAL)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia. Primary Objective * To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231. * To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231. Secondary Objectives * To assess the event free and overall survival of patients treated with this therapy. * To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.

Official Title

SJALL23T: Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

Quick Facts

Study Start:2024-12-27
Study Completion:2033-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06390319

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Enrollment on INITIALL.
  2. * Age 1-18.99 years at the time of enrollment on INITIALL.
  3. * T-Acute lymphoblastic leukemia or lymphoblastic lymphoma or mixed phenotype acute leukemia/ lymphoma
  4. * No prior chemotherapy excluding therapy given on or allowed by INITIALL.
  5. * Patient has completed no more than 3 days of chemotherapy on INITIALL.
  6. * Direct bilirubin ≤ 1.5x the upper limit of normal for age
  7. * Alanine aminotransferase (ALT) ≤ 5x the upper limit of normal for age
  8. * Calculated glomerular filtration rate (GFR) ≥ 50 mL/min/1.73m\^2 using the Bedside Schwartz equation OR creatinine below or equal to the maximum defined below:
  9. * Age: 1 to \< 2 years - Maximum serum creatinine (mg/dL): 0.6 (Male), 0.6 (Female)
  10. * Age: 2 to \< 6 years - Maximum serum creatinine (mg/dL): 0.8 (Male), 0.8 (Female)
  11. * Age: 6 to \< 10 years - Maximum serum creatinine (mg/dL): 1 (Male), 1 (Female)
  12. * Age: 10 to \< 13 years - Maximum serum creatinine (mg/dL): 1.2 (Male), 1.2 (Female)
  13. * Age: 13 to \< 16 years - - Maximum serum creatinine (mg/dL): 1.5 (Male), 1.4 (Female)
  14. * Age: ≥ 16 years - Maximum serum creatinine (mg/dL): 1.7 (Male), 1.4 (Female)
  1. * Inability or unwillingness to give informed consent/ assent as applicable.
  2. * Patients with \> Grade 2 neuropathy at the time of enrollment (participant with T-LLy only).
  3. * Documented malabsorption syndrome or any other condition that precludes receipt of oral medications.
  4. * Known HIV infection or active hepatitis B (defined as hepatitis B surface antigen-positive) or C (defined as hepatitis C antibody-positive).
  5. * Pregnant or lactating.
  6. * For patients of reproductive potential, unwillingness to use highly effective contraception for the duration of protocol therapy and for 90 days afterwards.
  7. * Receipt of a strong or moderate CYP3A4 inducer such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of protocol treatment.
  8. * Consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days of the start of protocol therapy.

Contacts and Locations

Study Contact

Seth E. Karol, MD, MSCI
CONTACT
866-278-5833
referralinfo@stjude.org

Principal Investigator

Seth E. Karol, MD, MSCI
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Seth E. Karol, MD, MSCI, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-27
Study Completion Date2033-12

Study Record Updates

Study Start Date2024-12-27
Study Completion Date2033-12

Terms related to this study

Keywords Provided by Researchers

  • Newly Diagnosed
  • Children
  • Young Adults
  • T-cell Acute Lymphoblastic Leukemia
  • T-cell Lymphoma
  • Mixed Phenotype Acute Leukemia (MPAL)

Additional Relevant MeSH Terms

  • T-cell Acute Lymphoblastic Leukemia
  • T-cell Lymphoma
  • Mixed Phenotype Acute Leukemia