A Phase 1-2 Study Assessing Total Therapy for Infants with Acute Lymphoblastic Leukemia

Full Title

TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II (POE23-01) (POETIC)

Purpose

Acute lymphoblastic leukemia (ALL) in infants (babies under 1 year of age) can be challenging to treat. Researchers in this study are assessing the addition of 2 new drugs to standard chemotherapy for ALL in infants.

One of the drugs is called blinatumomab, an immunotherapy medication already used to treat some people with ALL. The other is ziftomenib, which will be assessed in some infants who have a mutation in the KMT2A gene.

If your child takes part in this study, they will receive multiple rounds of chemotherapy to achieve remission. Remission means there is no evidence of leukemia and there are normal blood cells. We will continue the chemotherapy to keep your child in remission for a long time. Your child may be treated for up to 2.5 years, depending on how their leukemia responds to the study therapy.

Who Can Join

To join this study, there are a few conditions. Your child must:

  • Have newly diagnosed ALL that has not been treated with anything more than very limited therapy.
  • Have ALL that makes the CD19 protein.
  • Be age 1 year or younger.

Contact

For more information and to see if your child can join this study, please call 1-833-MSK-KIDS.

Protocol

25-142

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05848687