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)

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how adding two different chemotherapy drugs, dasatinib or venetoclax, can help improve treatment outcomes for children and young adults who have just been diagnosed with T-cell acute lymphoblastic leukemia (T-ALL), T-cell lymphoma, or mixed phenotype acute leukemia (MPAL). The main goal is to see if these drugs can help patients achieve a better response to treatment, specifically aiming for a certain level of cancer-free cells at the end of the initial treatment phase.

To participate in this trial, children and young adults aged between 1 and 18 years old who have been diagnosed with these types of leukemia or lymphoma are eligible, provided they haven’t received much prior chemotherapy. Participants can expect to receive either dasatinib or venetoclax along with standard treatment, and doctors will monitor their progress closely, including any side effects they may experience. This trial is currently recruiting participants, and it’s an important opportunity for families to consider if their child has recently been diagnosed with these conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Enrollment on INITIALL.
• • Age 1-18.99 years at the time of enrollment on INITIALL.
• • T-Acute lymphoblastic leukemia or lymphoblastic lymphoma or mixed phenotype acute leukemia/ lymphoma
• • No prior chemotherapy excluding therapy given on or allowed by INITIALL.
• • Patient has completed no more than 3 days of chemotherapy on INITIALL.
• • Direct bilirubin ≤ 1.5x the upper limit of normal for age
• • Alanine aminotransferase (ALT) ≤ 5x the upper limit of normal for age
• * 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:
• • Age: 1 to \< 2 years - Maximum serum creatinine (mg/dL): 0.6 (Male), 0.6 (Female)
• • Age: 2 to \< 6 years - Maximum serum creatinine (mg/dL): 0.8 (Male), 0.8 (Female)
• • Age: 6 to \< 10 years - Maximum serum creatinine (mg/dL): 1 (Male), 1 (Female)
• • Age: 10 to \< 13 years - Maximum serum creatinine (mg/dL): 1.2 (Male), 1.2 (Female)
• • Age: 13 to \< 16 years - - Maximum serum creatinine (mg/dL): 1.5 (Male), 1.4 (Female)
• • Age: ≥ 16 years - Maximum serum creatinine (mg/dL): 1.7 (Male), 1.4 (Female)
• Exclusion Criteria:
• • Inability or unwillingness to give informed consent/ assent as applicable.
• • Patients with \> Grade 2 neuropathy at the time of enrollment (participant with T-LLy only).
• • Documented malabsorption syndrome or any other condition that precludes receipt of oral medications.
• • Known HIV infection or active hepatitis B (defined as hepatitis B surface antigen-positive) or C (defined as hepatitis C antibody-positive).
• • Pregnant or lactating.
• • For patients of reproductive potential, unwillingness to use highly effective contraception for the duration of protocol therapy and for 90 days afterwards.
• • 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.
• • Consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days of the start of protocol therapy.