NCT05848687 · Tanja Andrea Gruber
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Dexamethasone
Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
DRUG
Mitoxantrone
Given IV
DRUG
PEG asparaginase
Given IV
DRUG
Bortezomib
Given IV
DRUG
Vorinostat
Taken PO or NG
DRUG
Mercaptopurine
Given PO or NG.
DRUG
Methotrexate
Given IV, IM or PO
DRUG
Blinatumomab
Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction
DRUG
Ziftomenib
3+3 dose escalation will be done. Dose level 1 will start at 75% of the adult recommended phase two dosing which has been established in phase I studies. Based on tolerability, we will either de-escalate to 50% RP2D (dose level -1) or escalate to 100% RP2D
Primary outcome measures
Minimal Residual Disease
Time frame: 5 years and 2 months
Proportion of patients who are minimal residual disease positive at the end of Induction Intensification
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 guar
Where
- Phoenix, Arizona
- Little Rock, Arkansas
- Los Angeles, California
- Madera, California
- Orange, California
- Palo Alto, California
- San Diego, California
- Orlando, Florida
- Minneapolis, Minnesota
- New York, New York
- Charlotte, North Carolina
- Portland, Oregon
And 5 more locations — see the full list below.
Collaborators
The Pediatric Oncology Experimental Therapeutics Investigators' Consortium, Amgen, Lucile Packard Foundation for Children's Health, Kura Oncology, Inc., United States Department of Defense, Cannonball Kid's Cancer
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations