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

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.

Conditions

• Lymphoblastic Leukemia

Interventions

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

Sponsors & Collaborators

• The Pediatric Oncology Experimental Therapeutics Investigators' Consortium

  collaborator OTHER

• Amgen

  collaborator INDUSTRY

• Lucile Packard Foundation for Children's Health

  collaborator UNKNOWN

• Kura Oncology, Inc.

  collaborator INDUSTRY

• United States Department of Defense

  collaborator FED

• Cannonball Kid's Cancer

  collaborator UNKNOWN

• Tanja Andrea Gruber

  lead OTHER

Principal Investigators

• Tanja A Gruber, MD, PhD · Stanford University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-03

Primary Completion

2028-12-31

Completion

2033-12-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations