Improving treatment for infants with acute lymphoblastic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance the treatment protocol for infants diagnosed with acute lymphoblastic leukemia (ALL) by testing the effectiveness of an immunotherapy called blinatumomab, which targets CD19 on leukemia cells. The study will involve a combination of medications including dexamethasone, mitoxantrone, PEG asparaginase, bortezomib, and vorinostat. It is designed for infants aged 365 days or younger with newly diagnosed CD19 positive ALL or acute undifferentiated leukemia, with limited prior therapy. The goal is to clear persistent leukemia and improve patient outcomes.

Why it matters

Who can join: the full rules

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. 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.

Exclusion Criteria:

* Patients with prior therapy, other than therapy specified in inclusion criteria.
* Patients with mature B-cell ALL that do not have a KMT2A rearrangement 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

Where it's running

• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• Valley Children's Hospital
  Madera, California, United States Recruiting
• Children's Hospital of Orange County
  Orange, California, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: Tanja A Gruber, MD, PhD — Stanford University
• Study coordinator: Tanja A Gruber, MD, PhD
• Email: tagruber@stanford.edu
• Phone: 650 723 5535

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.