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NCT05848687 · ClinicalTrials.gov registry record · Phase 1
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
A Phase 1 study of Lymphoblastic Leukemia, sponsored by Tanja Andrea Gruber.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT05848687: Recruiting Phase 1 study of Lymphoblastic Leukemia, sponsored by Tanja Andrea Gruber.
NCT05848687 is a Phase 1 study of Lymphoblastic Leukemia that is actively recruiting participants, run by Tanja Andrea Gruber. The registered enrollment target is 90 participants, above the 28-participant average among 6 other Lymphoblastic Leukemia trials with a reported enrollment target (221% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05848687, a Phase 1 study of Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Tanja Andrea Gruber.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Proportion of patients who are minimal residual disease positive at the end of Induction Intensification
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 |
What NCT05848687 shows while recruiting
NCT05848687 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 28-participant average among 6 other Lymphoblastic Leukemia trials with a reported enrollment target (221% higher).
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.
NCT05848687 names 20 study sites across 14 states, led by California, Texas, Alberta.
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.
What interventions are being tested in trial NCT05848687?
The interventions under investigation include: Dexamethasone (DRUG), Mitoxantrone (DRUG), PEG asparaginase (DRUG), Bortezomib (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT05848687?
This trial is sponsored by Tanja Andrea Gruber, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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