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Lymphoblastic LeukemiaPhase 1/2NCT05848687

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

A Phase 1/2 study testing Dexamethasone, Mitoxantrone and PEG asparaginase in people with Lymphoblastic Leukemia, run by Tanja Andrea Gruber at 24 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 1 year
Conditions the study is for
Lymphoblastic Leukemia
What is being tested?
Dexamethasone, Mitoxantrone and PEG asparaginase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
24 sitesin 2 countries
Study dates
3 Nov 2023to Dec 2033
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 1 year
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

24 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Tanja A Gruber, MD, PhD contact

650 723 5535

tagruber@stanford.edu

24 sites in 2 countries

United States17 sites, 17 recruiting

  • Novant Health - Hemby Children's Hospital

    Charlotte, North Carolina, 28204

    Christine Bolen, MD, 704-384-1900, cybolen@novanthealth.org

    Christine Bolen, MD

    Not yet recruiting

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

    Valerie Brown, MD,PhD, 717-531-6012, vbrown1@pennstatehealth.psu.edu

    Valerie Brown, Md, PhD

    Recruiting

  • MD Anderson

    Houston, Texas, 77030

    David McCall, MD, 717-792-6604, dmccall1@mdanderson.org

    Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

    Kevin Bielamowicz, MD, 501-364-4405, kjbielamowicz2@uams.edu

    Kevin Bielamowicz, MD

    Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

    Deepa Bhojwani, MD, 323-361-5922, dbhojwani@chla.usc.edu

    Amber Medina, 323-361-5654, ammedina@chla.usc.edu

    Recruiting

  • Valley Children's Hospital

    Madera, California, 93636

    Faisal Razzaqi, MD, 559-353-3000, FRazzaqi@valleychildrens.org

    Faisal Razzaqi, MD

    Recruiting

  • Children's Hospital of Minnesota

    Minneapolis, Minnesota, 55404

    Michael K Richards, MD, PhD, 612-813-5940, michael.richards@childrensmn.org

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

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Tanya Trippett, MD, 212-639-8267, trippet1@mskcc.org

    Tanya Trippett, MD

    Recruiting

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507

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

    ccbdcresearch@chkd.org

    Recruiting

  • Children's Hospital of Orange County

    Orange, California, 92868

    Jamie N Frediani, MD, 714-509-8636, jfrediani@choc.org

    Dorian Chan, 714-509-8646, DChan@choc.org

    Recruiting

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806

    Claudia Zapata, MD, 321-841-8588, claudia.zapata@orlandohealth.com

    Marie Frankos, 321-842-8738, marie.frankos@orlandohealth.com

    Recruiting

  • Stanford University

    Palo Alto, California, 94304

    Tanja A Gruber, MD, PhD, 650 723 5535, tagruber@stanford.edu

    Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

    Chris Oless, RN, 602-933-0920, coless@phoenixchildrens.com

    Dana Salzberg, MD

    Recruiting

  • Doernbecher Children's Hospital

    Portland, Oregon, 97239

    Bill Hoon Chang, Md, PhD, 503-346-0640, changb@ohsu.edu

    Bill Hoon Chang, MD, PhD

    Recruiting

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84108

    David S Mangum, MD, 801-662-4700, Spencer.Mangum@hsc.utah.edu

    David Mangum, MD

    Recruiting

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229

    Jaclyn Hung Y Hung, PhD, 210-567-7477, hungj@uthscsa.edu

    Anne-Marie Langevin, MD

    Recruiting

  • Rady Children's Hospital San Diego

    San Diego, California, 92123

    Deborah Schiff, MD, 858-966-5811, dschiff@rchsd.org

    Deborah Schiff, MD

    Not yet recruiting

Other trials in United States

Canada7 sites, 7 recruiting

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

    Victor Lewis, 1-403-955-7203, Victor.Lewis@albertahealthservices.ca

    Victor Lewis, MD

    Not yet recruiting

  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 2B7

    Sunil Desai, 1-780-407-8798, Sunil.Desai@albertahealthservices.ca

    Sunil J Desai, MD

    Not yet recruiting

  • McMaster Children's Hospital

    Hamilton, Ontario, L8N 3Z5

    Uma Athale, MD, 1-905-525-9140, athaleu@mcmaster.ca

    Uma Athale, MD

    Not yet recruiting

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

    Thai Hoa Tran, MD, 1-514-345-4931, thaihoa.tran@recherchestejustine.qc.ca

    Thai Hoa Tran, MD

    Not yet recruiting

  • Montreal Children's Hospital

    Montreal, Quebec, H4A 3J1

    Stephanie Mourad, MD, 1-514-412-4400, stephanie.mourad@mcgill.ca

    Stephanie Mourad, MD

    Not yet recruiting

  • Chu De Quebec

    Québec, Quebec, G1V 4G2

    Bruno Michon, MD, 1-418-654-2158, bruno.michon.med@ssss.gouv.qc.ca

    Bruno Michon, MD

    Not yet recruiting

  • BC Children's Hospital

    Vancouver, British Columbia, V6H 3V4

    Amanda Li, MD, 1-604-875-2345, ali3@cw.bc.ca

    Amanda Li, MD

    Not yet recruiting

Other trials in Canada

About this study

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.

Being tested
Dexamethasone, Mitoxantrone, PEG asparaginase, Bortezomib, Vorinostat
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

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

  • MitoxantroneDrug

    Given IV

  • PEG asparaginaseDrug

    Given IV

  • BortezomibDrug

    Given IV

  • VorinostatDrug

    Taken PO or NG

  • MercaptopurineDrug

    Given PO or NG.

  • MethotrexateDrug

    Given IV, IM or PO

  • BlinatumomabDrug

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

  • ZiftomenibDrug

    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

Study groups in NCT05848687
Study groupRoleWhat they receive
TreatmentExperimentalParticipants 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
Receives: Drug: Dexamethasone; Drug: Mitoxantrone; Drug: PEG asparaginase; Drug: Bortezomib; Drug: Vorinostat; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Blinatumomab; Drug: Ziftomenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minimal Residual Disease

    Proportion of patients who are minimal residual disease positive at the end of Induction Intensification

    Measured: 5 years and 2 months

Secondary outcomes (3)

  1. Ziftomenib Minimum safe and Biologically-Effective Dose in Combination with Chemotherapy

    To determine the estimated minimum safe and biologically-effective dose of Ziftomenib in combination with chemotherapy, on the basis of observed DLTs, MRD assessments, and pharmacokinetic studies

    Measured: 5 years and 6 months

  2. Event Free Survival

    To estimate the 3-year event-free survival for subjects treated on study

    Measured: 8 years

  3. Overall Survival

    To estimate the 3-year overall survival for subjects treated on study

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2023
  2. Study start3 Nov 2023
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05848687
Sponsor's protocol ID
IRB-68271
Other IDs
PEDSHEMALL0015, NCI-2023-04129
Status last verified
May 2026
First submitted
27 Apr 2023
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.

    PubMed 41671463

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dexamethasone, Mitoxantrone and PEG asparaginase in people with Lymphoblastic Leukemia, run by Tanja Andrea Gruber at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tanja A Gruber, MD, PhD (650 723 5535, tagruber@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimal Residual Disease (time frame: 5 years and 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05848687, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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