Clinical trial for Lymphoblastic Leukemia
Official title TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
ClinicalTrials.gov ID: NCT05848687
What this study is testing
What is Dexamethasone?
An investigational drug being studied for the treatment of lymphoblastic leukemia. It is designed to reduce inflammation and modulate immune activity in the body.
Also referred to as Dexamethasone.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to improve on the previous TINI trial by evaluating whether blinatumomab can clear remaining leukemia cells.
- Who it's for
- Infants diagnosed with acute lymphoblastic leukemia.
- What's involved
- Participants will receive blinatumomab, a type of immunotherapy that targets CD19 on leukemia cells.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 1
You may be able to join if
- Patient is ≤ 365 days of age at the time of diagnosis.
- Patient has newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia.
- Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, cytarabine for 72 hours or less...
- Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
You likely can't join if
- Patients with prior therapy, other than therapy specified in inclusion criteria.
- Patients with mature B-cell ALL that do not have a KMT2A rearrangement or patients with acute myelogenous (AML) or T-cell ALL.
- Patients with Down syndrome.
- Inability or unwillingness of legal guardian/representative to give written informed consent
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Madera, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- Orlando, Florida, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Portland, Oregon, United States
- Hershey, Pennsylvania, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 1 year. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Madera, California, United States; Orange, California, United States; Palo Alto, California, United States and 10 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.