OncoMatch/Clinical Trials/NCT05848687
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Is NCT05848687 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for lymphoblastic leukemia.
Treatment: Dexamethasone · Mitoxantrone · PEG asparaginase · Bortezomib · Vorinostat · Mercaptopurine · Methotrexate · Blinatumomab · Ziftomenib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 positive
Required: KMT2A (MLL) rearrangement
Demographics
Prior therapy
Cannot have received: any prior therapy other than specified
Exception: 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
Patients with prior therapy, other than therapy specified in inclusion criteria.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Phoenix Children's Hospital · Phoenix, Arizona
- Arkansas Children's Hospital · Little Rock, Arkansas
- Children's Hospital Los Angeles · Los Angeles, California
- Valley Children's Hospital · Madera, California
- Children's Hospital of Orange County · Orange, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05848687 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Does this trial require KMT2A?
Yes, KMT2A rearrangement is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 1 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify