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Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA with High Risk T-Cell ALL & Lymphoma
Sponsor: New York Medical College
Summary
A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, adolescents, and young adults (CAYA) with high risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). Pre- and post-HCT NGS-MRD studies will be correlated with outcomes in children, adolescents, and young adults with T-ALL undergoing allogeneic HCT and post-HCT DARA treatment. The study will also evaluate T-cell repertoire and immune reconstitution prior to and following DARA post-HCT treatment and correlate with patient outcomes.
Official title: Phase I Trial of Targeted Immunotherapy with Daratumumab Following Myeloablative TBI-Based Conditioning and AlloHCT in Children, Adolescents and Young Adults with High Risk T-Cell Acute Lymphoblastic Leukemia and Lymphoma (ALLO-T-DART)
Key Details
Gender
All
Age Range
Any - 39 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-05-22
Completion Date
2028-09
Last Updated
2025-03-13
Healthy Volunteers
No
Interventions
Daratumumab
Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor. Daratumumab (DARA) treatment post-HCT Phase 1: 3 dose levels to determine safety (15 patients) Dose expansion: 1. Induction: DARA IV weekly x 8 doses (Weeks 1-8) 2. Consolidation: DARA every 2 weeks x 8 doses (Weeks 9-24) 3. Maintenance: DARA every 4 weeks (Stop at Day +270)
Locations (16)
Phoenix Children's Hospital
Phoeniz, Arizona, United States
Loma Linda University Children's Hospital
Loma Linda, California, United States
University of California
Los Angeles, California, United States
University of California
San Francisco, California, United States
Children's Hospital Colordao
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida
Gainsville, Florida, United States
John Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Riley Children's Hospital
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
New York Medical College
Vallhala, New York, United States
Nationwide Children's Hosptial
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States