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

Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848687
• Other study ID #: IRB-68271
• Secondary ID: PEDSHEMALL0015
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 3, 2023
• Est. completion date: December 2033

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Tanja A Gruber, MD, PhD
• Phone: 650 723 5535
• Email: tagruber[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2033
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Dexamethasone
Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
• Mitoxantrone
Given IV
• PEG asparaginase
Given IV
• Bortezomib
Given IV
• Vorinostat
Taken PO or NG
• Mercaptopurine
Given PO or NG.
• Methotrexate
Given IV, IM or PO
• Blinatumomab
Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction
• 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

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (5)

Lead Sponsor	Collaborator
Tanja Andrea Gruber	Amgen, Kura Oncology, Inc., Lucile Packard Foundation for Children's Health, Pediatric Oncology Experimental Therapeutics Investigators' Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal Residual Disease	proportion of patients who are minimal residual disease positive at the end of induction intensification	5 years and 2 months
Secondary	Ziftomenib Maximum Tolerated Dose in Combination with Chemotherapy	determine the estimated maximum tolerated dose of Ziftomenib in combination with chemotherapy, on the basis of observed DLTs	5 years and 6 months
Secondary	Event Free Survival		8 years
Secondary	Overall Survival		8 years