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)
NCT ID: NCT06390319
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2024-12-27
2033-12-31
Brief Summary
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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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Detailed Description
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Treatment will consist of 3 main phases: Induction, Early Post Induction \[including Consolidation, High-Dose Methotrexate, Intensification, Interim 1, Reinduction 1, Interim 2, and Reinduction 2\], and Maintenance.
Induction:
* Remission Induction includes 3 days of therapy on the INITIALL classification protocol as well as the remainder of a total of 4 weeks of induction treatment on this trial. Treatment includes a total of 28 days of dexamethasone, 4 weekly doses of vincristine, 3 doses of daunorubicin, 1 dose of Calaspargase pegol, 6 doses of Intrathecal triple therapy (IT MHA), and one of 3 additional drugs. Patients with T-ALL without near-ETP or ETP phenotype (hereafter referred to simply as T-ALL) will receive 25 days of dasatinib. Patients with ETP or near-ETP ALL as well as those with MPAL will receive 14 days of venetoclax. Patients with T-LLy will receive bortezomib. Patients will have a week without chemotherapy at the end of Induction, although patients with Induction failure (MRD ≥5% disease) will proceed directly to consolidation.
Early Post Induction:
* Consolidation will be given following completion of Remission Induction Therapy. Patients will receive 2 cycles of BFM-1b therapy (a single dose of cyclophosphamide at the start of week 1, 4 daily doses of cytarabine in two consecutive weeks, and 2 weeks of mercaptopurine) separated by a week of nelarabine. Patients will have a week without chemotherapy at the end of Consolidation.
* High-dose Methotrexate will be given for 4 cycles to all patients. Patients will also receive an intrathecal chemotherapy treatment with each of the 2-week cycles and will take oral mercaptopurine continuously if tolerated.
* Intensification will be given to patients with T-ALL or ETP/ near-ETP. This therapy includes a week of nelarabine, one week of combination cyclophosphamide and cytarabine, and 1 week of rest without chemotherapy.
* Interim Therapy 1 includes 6 weeks of oral mercaptopurine, 2 weeks (5 days of each week) of dexamethasone, and two doses (weeks 1 and 4) of daunorubicin, vincristine, and calaspargase pegol.
* Reinduction Therapy 1 will consist of 3 weekly doses of vincristine, 1 dose of daunorubicin and calaspargase pegol at the start of the first week, and dexamethasone for 7 days in the first and third weeks. Patients will also receive the same additional agent received during induction based on immunophenotype.
* Interim Therapy 2 includes 6 weeks of oral mercaptopurine, two doses (weeks 1 and 4) of daunorubicin, vincristine, and calaspargase pegol.
* Reinduction Therapy 2 will consist of 3 weekly doses of vincristine, 1 dose of daunorubicin and calaspargase pegol at the start of the first week, and dexamethasone for 7 days in the first and third weeks. Patients will also receive the same additional agent received during induction based on immunophenotype.
Maintenance therapy:
* Early Maintenance Therapy follows Reinduction 2 and lasts 31 weeks. Patients will receive mercaptopurine and methotrexate interrupted by 1 week of nelarabine (week 3), 5 cyclophosphamide/ cytarabine pulses, and every 4-week dexamethasone/ vincristine pulses. For the first 32 weeks, patients will also receive every 4-week pulses including 5 days of dexamethasone and 1 dose of vincristine. Patients will receive low-dose methotrexate in all weeks when they do not receive dexamethasone or vincristine. All patients will receive every 4-week intrathecal chemotherapy beginning 4 weeks after the week of nelarabine.
* Late Maintenance Therapy follows early maintenance and includes daily mercaptopurine, weekly methotrexate, and every 8-week intrathecal chemotherapy. It lasts a total of 44 weeks.
Duration of therapy is approximately 2¼ years. It is recommended that patients be followed every 4 months for 1 year, every 6 months for 1 year and then yearly until the patient is in remission for 10 years and is at least 18 years old.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Dexamethasone
Given orally (PO) or intravenously (IV).
Vincristine
Given IV.
Daunorubicin
Given IV.
Calaspargase pegol
Given IV.
Dasatinib
Given PO
Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Given Intrathecal (IT), Age adjusted.
Cyclophosphamide
Given IV.
Cytarabine
Given IV or IT.
Mercaptopurine
Given PO.
Nelarabine
Given IV
Methotrexate
Given IT, IV, PO or intramuscular (IM).
Thioguanine
Given PO (participants intolerant to mercaptopurine).
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
Dexamethasone
Given orally (PO) or intravenously (IV).
Vincristine
Given IV.
Daunorubicin
Given IV.
Calaspargase pegol
Given IV.
Venetoclax
Given PO (ETP, near-ETP, and MPAL only).
Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Given Intrathecal (IT), Age adjusted.
Cyclophosphamide
Given IV.
Cytarabine
Given IV or IT.
Mercaptopurine
Given PO.
Nelarabine
Given IV
Methotrexate
Given IT, IV, PO or intramuscular (IM).
Thioguanine
Given PO (participants intolerant to mercaptopurine).
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
Dexamethasone
Given orally (PO) or intravenously (IV).
Vincristine
Given IV.
Daunorubicin
Given IV.
Calaspargase pegol
Given IV.
Bortezomib
Given IV (T-LLy only).
Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Given Intrathecal (IT), Age adjusted.
Cyclophosphamide
Given IV.
Cytarabine
Given IV or IT.
Mercaptopurine
Given PO.
Methotrexate
Given IT, IV, PO or intramuscular (IM).
Thioguanine
Given PO (participants intolerant to mercaptopurine).
Interventions
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Dexamethasone
Given orally (PO) or intravenously (IV).
Vincristine
Given IV.
Daunorubicin
Given IV.
Calaspargase pegol
Given IV.
Dasatinib
Given PO
Venetoclax
Given PO (ETP, near-ETP, and MPAL only).
Bortezomib
Given IV (T-LLy only).
Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Given Intrathecal (IT), Age adjusted.
Cyclophosphamide
Given IV.
Cytarabine
Given IV or IT.
Mercaptopurine
Given PO.
Nelarabine
Given IV
Methotrexate
Given IT, IV, PO or intramuscular (IM).
Thioguanine
Given PO (participants intolerant to mercaptopurine).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 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)
Exclusion Criteria
* 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.
1 Year
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Seth E. Karol, MD, MSCI
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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Rady Children's Hospital
San Diego, California, United States
Saint Francis Children's Hospital
Tulsa, Oklahoma, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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NCI-2024-03015
Identifier Type: REGISTRY
Identifier Source: secondary_id
SJALL23T
Identifier Type: -
Identifier Source: org_study_id
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