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TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
NCT05848687 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to improve upon the TINI study treatment. The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Mitoxantrone
- DRUG PEG asparaginase
- DRUG Bortezomib
- DRUG Vorinostat
Study Locations (20)
California
- Children's Hospital Los Angeles — Los Angeles
- Valley Children's Hospital — Madera
- Children's Hospital of Orange County — Orange
- Stanford University — Palo Alto
- Rady Children's Hospital San Diego — San Diego
Texas
- MD Anderson — Houston
- University of Texas Health Science Center San Antonio — San Antonio
Alberta
- Alberta Children's Hospital — Calgary
- Stollery Children's Hospital — Edmonton
Arizona
- Phoenix Children's Hospital — Phoenix
Arkansas
- Arkansas Children's Hospital — Little Rock
Florida
- Arnold Palmer Hospital for Children — Orlando
Minnesota
- Children's Hospital of Minnesota — Minneapolis
New York
- Memorial Sloan Kettering Cancer Center — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-11-03 |
| Est. Completion | 2033-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05848687
The ClinicalTrials.gov registry entry for NCT05848687 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tanja Andrea Gruber, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05848687 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Texas, Alberta. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05848687 about?
NCT05848687 is a clinical study titled "TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II". The purpose of this study is to improve upon the TINI study treatment. The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.
What is the current status of trial NCT05848687?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2023-11-03. Estimated completion is 2033-12.
What conditions does trial NCT05848687 study?
This clinical trial studies the following conditions: Lymphoblastic Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05848687?
The interventions under investigation include: Dexamethasone (DRUG), Mitoxantrone (DRUG), PEG asparaginase (DRUG), Bortezomib (DRUG), Vorinostat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05848687?
This trial is sponsored by Tanja Andrea Gruber, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05848687 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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