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Purpose

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

Eligibility

Eligible Ages
Under 1 Year
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Texas Health Science Center San Antonio
San Antonio, Texas 78229
Contact:
Jaclyn Hung Y Hung, PhD
210-567-7477
hungj@uthscsa.edu

More Details

Status
Recruiting
Sponsor
Tanja Andrea Gruber

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.