RECRUITING

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

Description

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
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Related Conditions:

Lymphoblastic Leukemia

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Lymphoblastic Leukemia
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Madera

Valley Children's Hospital, Madera, California, United States, 93636

Orange

Children's Hospital of Orange County, Orange, California, United States, 92868

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

San Diego

Rady Children's Hospital San Diego, San Diego, California, United States, 92123

Orlando

Arnold Palmer Hospital for Children, Orlando, Florida, United States, 32806

Minneapolis

Children's Hospital of Minnesota, Minneapolis, Minnesota, United States, 55404

Minneapolis

Children's Hospital of Minnesota, Minneapolis, Minnesota, United States, 55404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

to 1 Year

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tanja Andrea Gruber,

Tanja A Gruber, MD, PhD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2033-12