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NCT06533748 · ClinicalTrials.gov registry record · Phase 2
Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
A Phase 2 study of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
- 2
- Study locations
NCT06533748: Recruiting Phase 2 study of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, sponsored by St. Jude Children's Research Hospital.
NCT06533748 is a Phase 2 study of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 128 participants, below the 381-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (66% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06533748, a Phase 2 study of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase II clinical trial testing the use of two antigen-directed therapies, inotuzumab and blinatumomab, as part of induction therapy for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma. Primary Objective * To assess if the flow-cytometry assessed MRD-negative remission rate following an immunotherapy-based Induction in NCI-high risk patients without favorable genetic features is higher than the results of similar patients treated on AALL1131. Secondary Objectives * To compare flow-cytometry assessed MRD-negative rates at the end of Induction for patients treated with this therapy compared to similar patients treated on TOT17. * To compare the rate of significant toxicities in patients treated with this therapy to those treated with standard-risk therapy on TOT17. * To assess the event free and overall survival of patients treated with this therapy.
Primary Outcome
Flow cytometry (preferred) or next generation sequencing measurement of bone marrow with \<0.01% leukemia with resolution of extramedullary disease at the end of induction (approximately day 29) and will be analyzed within 6 months of the last participant reaching the timepoint.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Vincristine
- DRUG Dasatinib
- DRUG Blinatumomab
- DRUG Inotuzumab
Study Locations (2)
Oklahoma
- Saint Francis Children's Hospital - Tulsa
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2025-01-23 |
| Est. Completion | 2034-05 |
| Phase | Phase 2 |
What NCT06533748 shows while recruiting
NCT06533748 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 381-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.
NCT06533748 reports a single indexed study location in Oklahoma, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06533748 about?
NCT06533748 is a clinical study titled "Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma". This is a Phase II clinical trial testing the use of two antigen-directed therapies, inotuzumab and blinatumomab, as part of induction therapy for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma. Primary Objective * To assess if the flow-cy...
What is the current status of trial NCT06533748?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2025-01-23. Estimated completion is 2034-05.
What conditions does trial NCT06533748 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma.
What interventions are being tested in trial NCT06533748?
The interventions under investigation include: Dexamethasone (DRUG), Vincristine (DRUG), Dasatinib (DRUG), Blinatumomab (DRUG), Inotuzumab (DRUG).
Who is sponsoring clinical trial NCT06533748?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06533748 being conducted?
This trial has 2 study locations across Oklahoma, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06533748's enrollment target sits among peer trials
128 41st of 131 higher than 91 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic 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.
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