๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-10

Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma (NCT04972942)

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)

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: New York Medical College

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Phoenix Children's Hospital โ€” Phoeniz, Arizona

Age range: Not specified to 39 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (16 Sites)

  • Phoenix Children's Hospital โ€” Phoeniz, Arizona
  • Loma Linda University Children's Hospital โ€” Loma Linda, California
  • University of California โ€” Los Angeles, California
  • University of California โ€” San Francisco, California
  • Children's Hospital Colordao โ€” Aurora, Colorado
  • Children's National Medical Center โ€” Washington D.C., District of Columbia
  • University of Florida โ€” Gainsville, Florida
  • John Hopkins All Children's Hospital โ€” St. Petersburg, Florida
  • Riley Children's Hospital โ€” Indianapolis, Indiana
  • Boston Children's Hospital โ€” Boston, Massachusetts
  • Helen DeVos Children's Hospital โ€” Grand Rapids, Michigan
  • New York Medical College โ€” Vallhala, New York
  • Nationwide Children's Hosptial โ€” Columbus, Ohio
  • Children's Hospital of Philadelphia โ€” Philadelphia, Pennsylvania
  • MD Anderson Cancer Center โ€” Houston, Texas
  • Medical College of Wisconsin โ€” Milwaukee, Wisconsin

๐Ÿ“ž Contact the Study Coordinator

Phone: (617) 285-7844

Email: lauren_harrison@nymc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—