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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05848687
Recruitment Status : Recruiting
First Posted : May 8, 2023
Last Update Posted : February 22, 2024
Sponsor:
Collaborators:
Pediatric Oncology Experimental Therapeutics Investigators' Consortium
Amgen
Lucile Packard Foundation for Children's Health
Kura Oncology, Inc.
Information provided by (Responsible Party):
Tanja Andrea Gruber, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lymphoblastic Leukemia Drug: Dexamethasone Drug: Mitoxantrone Drug: PEG asparaginase Drug: Bortezomib Drug: Vorinostat Drug: Mercaptopurine Drug: Methotrexate Drug: Blinatumomab Drug: Ziftomenib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Actual Study Start Date : November 3, 2023
Estimated Primary Completion Date : December 2028
Estimated Study Completion Date : December 2033

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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

 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Ziftomenib Maximum Tolerated Dose in Combination with Chemotherapy [ Time Frame: 5 years and 6 months ]
    determine the estimated maximum tolerated dose of Ziftomenib in combination with chemotherapy, on the basis of observed DLTs

  2. Event Free Survival [ Time Frame: 8 years ]
  3. Overall Survival [ Time Frame: 8 years ]

Eligibility Criteria
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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with CD19 positive biphenotypic acute leukemia are eligible. Patients with CD19 positive mature B-cell ALL that carry a KMT2Ar 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 does not have a KMT2Ar 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05848687


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

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Tanja A Gruber, MD, PhD    650-723-5535    tagruber@stanford.edu   
Sponsors and Collaborators
Tanja Andrea Gruber
Pediatric Oncology Experimental Therapeutics Investigators' Consortium
Amgen
Lucile Packard Foundation for Children's Health
Kura Oncology, Inc.
Investigators
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Principal Investigator: Tanja A Gruber, MD, PhD Stanford University
More Information
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Responsible Party: Tanja Andrea Gruber, Faculty - Hematology/Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT05848687    
Other Study ID Numbers: IRB-68271
PEDSHEMALL0015 ( Other Identifier: Stanford OnCore )
First Posted: May 8, 2023    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Methotrexate
Bortezomib
Asparaginase
Mercaptopurine
 Mitoxantrone
Vorinostat
Blinatumomab
Pegaspargase
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents