RECRUITING

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

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Conditions

Lymphoblastic Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-03
Study Completion:2033-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05848687

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.

Ages Eligible for Study:Not specified to 1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patient is ≤ 365 days of age at the time of diagnosis.
  2. * 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.
  3. * 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.
  4. * Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
  1. * Patients with prior therapy, other than therapy specified in inclusion criteria.
  2. * Patients with mature B-cell ALL that do not have a KMT2A rearrangement or patients with acute myelogenous (AML) or T-cell ALL.
  3. * Patients with Down syndrome.
  4. * Inability or unwillingness of legal guardian/representative to give written informed consent

Contacts and Locations

Study Contact

Tanja A Gruber, MD, PhD
CONTACT
650 723 5535
tagruber@stanford.edu

Principal Investigator

Tanja A Gruber, MD, PhD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Valley Children's Hospital
Madera, California, 93636
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Stanford University
Palo Alto, California, 94304
United States
Rady Children's Hospital San Diego
San Diego, California, 92123
United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
United States
Children's Hospital of Minnesota
Minneapolis, Minnesota, 55404
United States
Children's Hospital of Minnesota
Minneapolis, Minnesota, 55404
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Novant Health - Hemby Children's Hospital
Charlotte, North Carolina, 28204
United States
Doernbecher Children's Hospital
Portland, Oregon, 97239
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
MD Anderson
Houston, Texas, 77030
United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84108
United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Tanja Andrea Gruber

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-03
Study Completion Date2033-12

Study Record Updates

Study Start Date2023-11-03
Study Completion Date2033-12

Terms related to this study

Additional Relevant MeSH Terms

  • Lymphoblastic Leukemia