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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: Recruiting Phase 2 study of Mixed Phenotype Acute Leukemia and T-Cell Lymphoma, sponsored by St. Jude Children's Research Hospital.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Comparison of the probability of achieving negative MRD (\<0.01%) and M1 bone marrow status at the end of induction between this protocol and COG AALL1231 will be performed. Statistical analysis of the primary objective will be conducted according to a group sequential design with 1 interim analysis, by a slightly modified version of the procedure for binary endpoint.

Conditions Studied

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

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

FieldValue
Enrollment Target 100 participants
Start Date 2024-12-27
Est. Completion 2033-12
Phase Phase 2
St. Jude Children's Research Hospital

410 total trials

What NCT06390319 shows while recruiting

NCT06390319 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 396-participant average among 29 other Mixed Phenotype Acute Leukemia trials with a reported enrollment target (75% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Mixed Phenotype Acute Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06390319's enrollment target sits among peer trials

100 12th of 29 higher than 17 of 29 other Mixed Phenotype Acute Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Mixed Phenotype Acute Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06390319

Source: ClinicalTrials.gov NCT06390319, the US trial registry maintained by the National Library of Medicine. NCT06390319 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.