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)

StatusRecruiting

PhasePhase 2

SponsorSt. Jude Children's Research Hospital

Started2024-12-27

View on ClinicalTrials.gov ↗

Amendment history

2026-08-07

Study Status v16

Re-verified, no change to tracked fields

2026-07-15

Study Status, Contacts/Locations v15

Study sites3→4

2026-04-29

Study Status, Contacts/Locations v14

Study sitescontacts updated at 1 of 3 sites

2026-02-24

Study Status v13

Re-verified, no change to tracked fields

2025-09-22

Study Status, Contacts/Locations v12

Study sites2→3

Show 11 earlier versions

2025-07-11

Study Status, Contacts/Locations v11

Study sites1→2

2025-03-21

Study Status v10

Re-verified, no change to tracked fields

2025-01-31

Study Status, Study Design v9

Enrollment target145→100

2025-01-10

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v8

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2025-01→confirmed 2024-12-27

Study sitesdetails revised at 1 of 1 site

2024-12-13

Study Status v7

Start date2024-12→2025-01

2024-11-07

Study Status v6

Start date2024-11→2024-12

2024-10-08

Study Status, Eligibility v5

Start date2024-10→2024-11

Eligibility criteria+721 characters

[...] 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 [...] Exclusion Criteria: Inability or unwillingness to give infor [...] hn's wort within 7 days of the start of protocol treatment. ~~For patients with ETP ALL, near-ETP ALL, and MPAL: consumption~~Consumption of grapefruit, grapefruit products, Seville or [...]

2024-08-16

Study Status v4

Start date2024-08→2024-10

2024-07-23

Study Status v3

Start date2024-07→2024-08

2024-06-17

Study Status v2

Start date2024-06→2024-07

2024-05-23

Study Status v1

Start date2024-05→2024-06

2024-04-25

Original filing

St. Jude Children's Research Hospital

180 trials monitored

See 16 trials at risk

Leukemia

2,553 trials monitored

See 134 trials at risk

Non-Hodgkin Lymphoma

1,512 trials monitored

See 79 trials at risk

Acute Lymphoblastic Leukemia (ALL)

873 trials monitored

See 52 trials at risk

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.

Trial Details

NCT Number	NCT06390319
Lead Sponsor	St. Jude Children's Research Hospital Collaborators: AbbVie
Conditions	T-cell Acute Lymphoblastic Leukemia, T-cell Lymphoma, Mixed Phenotype Acute Leukemia
Enrollment	100 participants
Start Date	2024-12-27
Primary Completion	2027-12 (estimated)
Study Completion	2033-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-10