Recruiting

Phase 1

Phase 2

TINI 2TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II

Sponsor:

Tanja Andrea Gruber

Code:

NCT05848687

Conditions

Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Mitoxantrone

PEG asparaginase

Bortezomib

Vorinostat

Study Details

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.

Conditions

Lymphoblastic Leukemia

Study ID

NCT05848687

Start date

Nov 3, 2023

Status verified date

May, 2026

Completion date

Dec, 2033

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance.

Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib

Interventions

Dexamethasone

Given orally (PO) or naso-gastrically (NG) or intravenously (IV).

Mitoxantrone

Given IV

PEG asparaginase

Given IV

Bortezomib

Given IV

Vorinostat

Taken PO or NG

Mercaptopurine

Given PO or NG.

Methotrexate

Given IV, IM or PO

Blinatumomab

Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction

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 measure

Minimal Residual Disease [ Time Frame: 5 years and 2 months ]

Central Contacts and Locations

Central contacts

Tanja A Gruber, MD, PhD

650 723 5535 tagruber@stanford.edu

Locations

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Chris Oless, RN

602-933-0920 coless@phoenixchildrens.com

Principal Investigator:

Dana Salzberg, MD

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Kevin Bielamowicz, MD

501-364-4405 kjbielamowicz2@uams.edu

Principal Investigator:

Kevin Bielamowicz, MD

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Deepa Bhojwani, MD

323-361-5922 dbhojwani@chla.usc.edu

Amber Medina

323-361-5654 ammedina@chla.usc.edu

Principal Investigator:

Deepa Bhojwani, MD

Valley Children's Hospital

Recruiting

Madera, California, United States, 93636

Contacts

Faisal Razzaqi, MD

559-353-3000 FRazzaqi@valleychildrens.org

Principal Investigator:

Faisal Razzaqi, MD

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Jamie N Frediani, MD

714-509-8636 jfrediani@choc.org

Dorian Chan

714-509-8646 DChan@choc.org

Principal Investigator:

Jamie N Frediani, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Tanja A Gruber, MD, PhD

650 723 5535 tagruber@stanford.edu

Arnold Palmer Hospital for Children

Recruiting

Orlando, Florida, United States, 32806

Contacts

Claudia Zapata, MD

321-841-8588 claudia.zapata@orlandohealth.com

Marie Frankos

321-842-8738 marie.frankos@orlandohealth.com

Principal Investigator:

Claudia P Zapata, MD

Children's Hospital of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Michael K Richards, MD, PhD

612-813-5940 michael.richards@childrensmn.org

Pauline Mitby

(612) 813-5913 pauline.mitby@childrensmn.org

Principal Investigator:

Michael K Richards, MD, PhD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Tanya Trippett, MD

212-639-8267 trippet1@mskcc.org

Principal Investigator:

Tanya Trippett, MD

Doernbecher Children's Hospital

Recruiting

Portland, Oregon, United States, 97239

Contacts

Bill Hoon Chang, Md, PhD

503-346-0640 changb@ohsu.edu

Principal Investigator:

Bill Hoon Chang, MD, PhD

Penn State Milton S Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033-0850

Contacts

Valerie Brown, MD,PhD

717-531-6012 vbrown1@pennstatehealth.psu.edu

Principal Investigator:

Valerie Brown, Md, PhD

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

David McCall, MD

717-792-6604 dmccall1@mdanderson.org

University of Texas Health Science Center San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Jaclyn Hung Y Hung, PhD

210-567-7477 hungj@uthscsa.edu

Principal Investigator:

Anne-Marie Langevin, MD

University of Utah Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

David S Mangum, MD

801-662-4700 Spencer.Mangum@hsc.utah.edu

Principal Investigator:

David Mangum, MD

Children's Hospital of The King's Daughters

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Eric Lowe, MD

757-668-7243 Eric.Lowe@chkd.org

ccbdcresearch@chkd.org

Principal Investigator:

Eric Lowe, MD

More Information

Sponsor

Tanja Andrea Gruber

Last update posted

Jun 3, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Tanja Andrea Gruber on 2026-06-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.