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NCT06390319 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Mixed Phenotype Acute Leukemia and T-Cell Lymphoma, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 3
- Study locations
NCT06390319 is a Phase 2 study of Mixed Phenotype Acute Leukemia and T-Cell Lymphoma that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 100 participants, below the 396-participant average among 29 other Mixed Phenotype Acute Leukemia trials with a reported enrollment target (75% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06390319, a Phase 2 study of Mixed Phenotype Acute Leukemia and T-Cell Lymphoma, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Vincristine
- DRUG Daunorubicin
- DRUG Dasatinib
- DRUG Calaspargase pegol
Study Locations (3)
California
- Rady Children's Hospital - San Diego
Oklahoma
- Saint Francis Children's Hospital - Tulsa
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-12-27 |
| Est. Completion | 2033-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06390319
The ClinicalTrials.gov registry entry for NCT06390319 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 396-participant average among 29 other Mixed Phenotype Acute Leukemia trials with a reported enrollment target (75% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Mixed Phenotype Acute Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.
NCT06390319 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Oklahoma, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06390319 about?
NCT06390319 is a clinical study titled "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)". 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 evalu...
What is the current status of trial NCT06390319?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-12-27. Estimated completion is 2033-12.
What conditions does trial NCT06390319 study?
This clinical trial studies the following conditions: Mixed Phenotype Acute Leukemia, T-Cell Lymphoma, T-cell Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT06390319?
The interventions under investigation include: Dexamethasone (DRUG), Vincristine (DRUG), Daunorubicin (DRUG), Dasatinib (DRUG), Calaspargase pegol (DRUG).
Who is sponsoring clinical trial NCT06390319?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06390319 being conducted?
This trial has 3 study locations across California, Oklahoma, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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