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Tyrosine Kinase Inhibitor

Patients with ETP or near-ETP ALL or MPAL for T-Cell Lymphoblastic 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

EFS compared to Total 17 (TOT17-NCT03117751)

Event-free survival (EFS)

Incidence of grade 4 toxicities

+2 more

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

~12330

Cyclophosphamide

1995

Completed Phase 3

~3770

Nelarabine

2008

Completed Phase 2

~500

Methotrexate

2013

Completed Phase 4

~3800

Bortezomib

2005

Completed Phase 2

~1090

Daunorubicin

2013

Completed Phase 4

~4940

Venetoclax

2019

Completed Phase 3

~1990

Dasatinib

2012

Completed Phase 3

~2320

Thioguanine

2012

Completed Phase 4

~10830

Dexamethasone

2007

Completed Phase 4

~2590

Vincristine

2003

Completed Phase 4

~2910

Cytarabine

2016

Completed Phase 3

~3310

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

429 Previous Clinical Trials

5,306,613 Total Patients Enrolled

AbbVieIndustry Sponsor

962 Previous Clinical Trials

502,968 Total Patients Enrolled

Seth E. Karol, MD, MSCIPrincipal InvestigatorSt. Jude Children's Research Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the specific criteria for eligibility to participate in this medical study?

"In order to qualify for participation, individuals must have t-cell acute lymphoblastic leukemia and fall between the ages of 12 months and 18 years. The study aims to enroll a total of 145 participants."

Answered by AI

Are there any ongoing opportunities for patients to participate in this medical trial?

"As per clinicaltrials.gov, recruitment for this trial is presently closed. The initial posting date was May 1st, 2024, with the latest edit made on April 25th, 2024. Despite this specific trial no longer accepting participants, there are currently a substantial number of 2934 other trials actively seeking eligible candidates at this time."

Answered by AI

What are the main goals and purposes of this investigation?

"The main goal of this clinical study is to determine the rate of MRD-negativity in patients with ETP or near ETP ALL, assessed by day 29 post-induction or at the time of mortality. Additional aims include evaluating grade 4 adverse events based on Common Terminology Criteria for Adverse Events version 5 and comparing them using Fisher's exact Chi-square test, examining event-free survival (EFS) through Kaplan-Meier estimates along with standard error calculations, and assessing overall survival (OS) using Kaplan-Meier estimates alongside standard error computations."

Answered by AI

Is the clinical trial open to individuals below 25 years of age?

"Eligible participants for this research endeavor must be between 1 and 18 years old. There are a total of 676 trials catered specifically to individuals below the age of majority, while there are 2496 clinical investigations tailored towards seniors over the age of retirement."

Answered by AI

What level of risk does T-ALL pose for individuals, excluding those with ETP or near-ETP?

"Given that this is a Phase 2 trial focusing on patients with T-ALL (excluding ETP or near-ETP), our team at Power rates their safety at level 2. This indicates some existing safety data, although efficacy evidence is currently lacking."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2024. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06390319.

All > Dasatinib