Health TrialsbyHealthPanel

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

ConditionLymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorTanja Andrea Gruber

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Dexamethasone

    Drug

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

  • Mitoxantrone

    Drug

    Given IV

  • PEG asparaginase

    Drug

    Given IV

  • Bortezomib

    Drug

    Given IV

  • Vorinostat

    Drug

    Taken PO or NG

  • Mercaptopurine

    Drug

    Given PO or NG.

  • Methotrexate

    Drug

    Given IV, IM or PO

  • Blinatumomab

    Drug

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

  • Ziftomenib

    Drug

    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

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Minimal Residual Disease

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

Time frame
5 years and 2 months

Secondary outcomes

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

Time frame
5 years and 6 months
2

Event Free Survival

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

Time frame
8 years
3

Overall Survival

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

Time frame
8 years

Other outcomes

Sponsors and contacts

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Tanja Andrea Gruber

Lead sponsor

Stanford University

Sponsor institution

The Pediatric Oncology Experimental Therapeutics Investigators' Consortium

Collaborator

Amgen

Collaborator

Lucile Packard Foundation for Children's Health

Collaborator

Kura Oncology, Inc.

Collaborator

United States Department of Defense

Collaborator

Cannonball Kid's Cancer

Collaborator

Source ClinicalTrials.gov
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