Total Therapy for Infants With Acute Lymphoblastic Leukemia II
TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II
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Clinical Trial Information
Trial Contact: Armatti, Julie M; Torrescano, Tanner; Singh, Sarah H; Jones, Jamie; Frankos, Marie; Parker, Melanie
Trial Phone: 321-843-5284 ; 321-841-8271 ; 321.841.7561 ; 3218412008 ; 321-842-8738 ; 321-843-1036
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IRB No: S25.057.03
Protocol Abbrev: TINI 2
Principal Investigator: Claudia P. Zapata, MD
Phase: Drug: Phase II
Age Group: Pediatric
Secondary Protocol No: POE23-01
Treatment: 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
ClinicalTrials.gov ID: NCT05848687
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Objective
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.
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Key Eligibility
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
