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)

Part of paid clinical trials in San Diego, California.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT06390319
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mixed Phenotype Acute Leukemia
  • T-cell Acute Lymphoblastic Leukemia
  • T-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Given orally (PO) or intravenously (IV).
  • Vincristine — DRUG
    Given IV.
  • Daunorubicin — DRUG
    Given IV.
  • Calaspargase pegol — DRUG
    Given IV.
  • Dasatinib — DRUG
    Given PO
  • Venetoclax — DRUG
    Given PO (ETP, near-ETP, and MPAL only).
  • Bortezomib — DRUG
    Given IV (T-LLy only).
  • Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) — DRUG
    Given Intrathecal (IT), Age adjusted.
  • Cyclophosphamide — DRUG
    Given IV.
  • Cytarabine — DRUG
    Given IV or IT.
  • Mercaptopurine — DRUG
    Given PO.
  • Nelarabine — DRUG
    Given IV
  • Methotrexate — DRUG
    Given IT, IV, PO or intramuscular (IM).
  • Thioguanine — DRUG
    Given PO (participants intolerant to mercaptopurine).

Study Details

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.

Key Dates

Start date
Dec 27, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2033

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with T-ALL (except ETP or near-ETP)
    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
  • Experimental: Patients with ETP or near-ETP ALL or MPAL
    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
  • Experimental: Patients with T-LLy
    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

Primary Outcome Measure

Minimal residual disease (MRD)-negativity rate in patients with T cell acute lymphoblastic leukemia [ Time Frame: Up to end of induction day 29 or death ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Rady Children's HospitalSan DiegoCalifornia92123
Victor Wong, MD
[email protected]
858-966-5811
Victor Wong, MD (PRINCIPAL_INVESTIGATOR)
Saint Francis Children's HospitalTulsaOklahoma74136
Ashraf Mohamed, MD
[email protected]
918-502-6720
Ashraf Mohamed, MD (PRINCIPAL_INVESTIGATOR)
St. Jude Children's Research HospitalMemphisTennessee38105
Seth E. Karol, MD, MSCI
[email protected]
888-226-4343
Seth E. Karol, MD, MSCI (PRINCIPAL_INVESTIGATOR)

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Rady Children's Hospital· San Diego, CASaint Francis Children's Hospital· Tulsa, OKSt. Jude Children's Research Hospital· Memphis, TN

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