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Tyrosine Kinase Inhibitor

Dasatinib or Venetoclax for T-Cell Leukemia

Phase 2

Waitlist Available

Led By Seth E. Karol, MD, MSCI

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of T-Acute lymphoblastic leukemia or lymphoblastic lymphoma or mixed phenotype acute leukemia/lymphoma

Age 1-18.99 years at the time of enrollment on INITIALL

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding either dasatinib or venetoclax to the treatment of children and young adults with certain types of leukemia can improve their outcomes. The main goal is to see if

Who is the study for?

This trial is for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia, lymphoma, or mixed phenotype acute leukemia. Specific eligibility criteria are not provided but typically include factors like age range, disease stage, and overall health status.

What is being tested?

The trial tests if adding dasatinib or venetoclax to standard chemotherapy improves outcomes in patients. It measures the rate of MRD-negative responses at the end of induction therapy and compares survival rates and severe toxicities to previous studies.

What are the potential side effects?

Potential side effects may include those common to chemotherapy such as nausea, hair loss, increased infection risk due to low blood cell counts, organ toxicity, fatigue, and possible allergic reactions to the drugs being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of leukemia or lymphoma.

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I am between 1 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable or unwilling to agree to the study's terms.

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I have severe nerve pain or damage.

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I have HIV or active hepatitis B or C.

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I cannot take pills due to a condition affecting my digestion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MRD-negativity rate in patients with ETP or near ETP ALL

Minimal residual disease (MRD)-negativity rate in patients with T cell acute lymphoblastic leukemia

Secondary study objectives

EFS compared to Total 17 (TOT17-NCT03117751)

Event-free survival (EFS)

Incidence of grade 4 toxicities

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Patients with T-LLyExperimental Treatment11 Interventions

All eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Bortezomib, IT MHA Early Post Induction: Cyclophosphamide, Cytarabine, Mercaptopurine, IT MHA, Methotrexate, Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Bortezomib Maintenance: Mercaptopurine, Methotrexate, Cyclophosphamide, Cytarabine, Dexamethasone, Vincristine, IT MHA, Thioguanine

Group II: Patients with T-ALL (except ETP or near-ETP)Experimental Treatment12 Interventions

All eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Dasatinib, IT MHA Early Post Induction: Cyclophosphamide, Cytarabine, Mercaptopurine, Nelarabine, IT MHA, Methotrexate, Dasatinib, Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol Maintenance: Mercaptopurine, Methotrexate, Nelarabine, Cyclophosphamide, Cytarabine, Dexamethasone, Vincristine, Dasatinib, IT MHA, Thioguanine

Group III: Patients with ETP or near-ETP ALL or MPALExperimental Treatment12 Interventions

All eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Venetoclax, IT MHA Early Post Induction: Cyclophosphamide, Cytarabine, Mercaptopurine, Nelarabine, IT MHA, Methotrexate, Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Venetoclax Maintenance: Mercaptopurine, Methotrexate, Nelarabine, Cyclophosphamide, Cytarabine, Dexamethasone, Vincristine, IT MHA, Thioguanine

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mercaptopurine

2012

Completed Phase 4

~13290

Daunorubicin

2013

Completed Phase 4

~5740