NCT05848687 TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
| NCT ID | NCT05848687 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Tanja Andrea Gruber |
| Condition | Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-11-03 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2023-11-03 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Subjects with bilineage or biphenotypic acute leukemia are eligible provided they express CD19. Patients with CD19 positive mature B-cell ALL who carry a KMT2A rearrangement are eligible. * Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, cytarabine for 72 hours or less, one dose of vincristine, and one dose of intrathecal chemotherapy. * Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines. Exclusion Criteria: * 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
Contact & Investigator
Tanja A Gruber, MD, PhD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT05848687 clinical trial?
This trial is open to participants of all sexes, up to 1 Year, studying Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05848687 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05848687 currently recruiting?
Yes, NCT05848687 is actively recruiting participants. Contact the research team at tagruber@stanford.edu for enrollment information.
Where is the NCT05848687 trial being conducted?
This trial is being conducted at Phoenix, United States, Little Rock, United States, Los Angeles, United States, Madera, United States and 11 additional locations.
Who is sponsoring the NCT05848687 clinical trial?
NCT05848687 is sponsored by Tanja Andrea Gruber. The principal investigator is Tanja A Gruber, MD, PhD at Stanford University. The trial plans to enroll 90 participants.
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.