Trial · NCT06390319
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)
NCT06390319, Phase 2, Recruiting, St. Jude Children's Research Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT06390319. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06390319
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT06390319
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 100 participants, estimated
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- T-cell Acute Lymphoblastic Leukemia, T-cell Lymphoma, Mixed Phenotype Acute Leukemia
- Interventions
Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Dasatinib, Venetoclax, Bortezomib, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine), Cyclophosphamide, Cytarabine, Mercaptopurine, Nelarabine, Methotrexate, Thioguanine
- First posted
- 2024-04-30
- Last updated
- 2026-08-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Minimal residual disease (MRD)-negativity rate in patients with T cell acute lymphoblastic leukemia | Up to end of induction day 29 or death | 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. |
| Primary | MRD-negativity rate in patients with ETP or near ETP ALL | Up to end of induction day 29 or death | The proportion of patients with ETP or near-ETP treated with venetoclax based induction will be compared to the rate of such unsuccessful induction in patients treated on AALL1231 with a standard 4-drug induction. The probability of achieving negative MRD will be tested using a one-sided exact binomial proportion test. |
| Secondary | Event-free survival (EFS) | Up to 10 years | Kaplan-Meier estimates for EFS will be calculated along with standard error. |
| Secondary | Overall survival (OS) | Up to 10 years | Kaplan-Meier estimates for OS will be calculated along with standard error. |
| Secondary | Incidence of grade 4 toxicities | Up to 30 days after last dose of study treatment | Adverse events will be graded using Common Terminology Criteria for Adverse Events version 5 and compared using Fisher's or exact Chi-square test. |
| Secondary | EFS compared to Total 17 (TOT17-NCT03117751) | Up to 10 years | Comparisons of EFS to the corresponding TOT17 will be performed by the log-rank test. |
| Secondary | OS compared to TOT17 | Up to 10 years | Comparisons of OS to the corresponding TOT17 will be performed by the log-rank test. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41619724 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06390319
GET https://conductscience.org/api/trials/v1/NCT06390319/registered