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

Summary and objectives

As childhood Acute Lymphoblastic Leukemia (ALL) outcomes continue to improve, infants younger than 1 year of age with KMT2A-rearranged (KMT2Ar) ALL remain difficult to cure. Rearrangement of KMT2A characterize a group of high-risk acute leukemias and accounts for approximately 70% to 80% of infantile ALL. While immunotherapy has recently been widely and successfully implemented in ALL, there are unique challenges associated with KMT2Ar-ALL in infants. Thus, effective therapies are still needed.

The goals of this study are to increase disease clearance and sustain deep remission through the use of the immunotherapy agent, blinatumomab. Additionally, this study seeks to determine the minimum safe and effective dose of the menin inhibitor, ziftomenib, when given in combination with chemotherapy at the beginning of treatment for refractory patients.

Eligibility criteria

In addition to a few criteria that could prevent participation, there are criteria participants must meet including but not limited to the following:

• Must have protocol-defined qualifying diagnosis
• Must be ≤ 365 days old at time of diagnosis
• Must not have Down Syndrome
• Must not have received prior therapies other than those deemed permissible within the protocol

Clinicaltrials.gov Study Details >