Clinical trial for T-cell Acute Lymphoblastic Leukemia
Official title 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)
ClinicalTrials.gov ID: NCT06390319
What this study is testing
What is Dexamethasone?
This is an investigational medicine being studied as part of a treatment plan for T-cell acute lymphoblastic leukemia. It is designed to reduce inflammation and help stop the growth of certain cancer cells.
Also referred to as Decadron, Hexadrol.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if adding one of two new drugs to standard chemotherapy helps more children clear the leukemia cells after the first round of treatment.
- Who it's for
- Children and young adults who have just been diagnosed with T-cell acute lymphoblastic leukemia, T-cell lymphoma, or mixed phenotype acute leukemia.
- What's involved
- Participants will receive standard chemotherapy plus either dasatinib or venetoclax. They will undergo regular blood tests and medical visits to monitor their health and how the leukemia is responding.
- Time commitment
- The study involves the full course of treatment, which typically lasts several months, with regular visits to the clinic for tests and check-ups.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 31 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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
- 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)
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
- Charlotte, North Carolina, United States
- Tulsa, Oklahoma, United States
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 31 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States; Charlotte, North Carolina, United States; Tulsa, Oklahoma, United States; Memphis, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.