Clinical trialNCT06390319RecruitingPhase 2Interventional

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)

SponsorSt. Jude Children's Research HospitalEnrollment100Mixed Phenotype Acute LeukemiaT-cell Acute Lymphoblastic LeukemiaT-cell Lymphoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Seth E. Karol, MD, MSCI
St. Jude Children's Research Hospital
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Rady Children'S Hospital
San Diego, California, United States
Victor Wong, MD
Recruiting
Novant Health Presbyterian Hemby Children'S Hospital
Charlotte, North Carolina, United States
Jessica Bell, MD
Recruiting
Saint Francis Children'S Hospital
Tulsa, Oklahoma, United States
Ashraf Mohamed, MD
Recruiting
St. Jude Children'S Research Hospital
Memphis, Tennessee, United States
Seth E. Karol, MD, MSCI →
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Bortezomib →Calaspargase pegol →Cyclophosphamide →Cytarabine →Dasatinib →Daunorubicin →Dexamethasone →Intrathecal triple therapyMercaptopurine →Methotrexate →NelarabineThioguanineVenetoclax →Vincristine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 27 Dec 2024
Primary completion: 31 Dec 2027
Completion: 31 Dec 2033
Last update posted: 10 Aug 2026
Registered enrollment: 100
Registry id: NCT06390319

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.