Summary

Eligibility
for people ages up to 39 years (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around

Description

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)

Details

Keywords

T-cell Acute Lymphoblastic Leukemia, T-Cell Acute Lymphoblastic Lymphoma, immunotherapy, children, adolescents, young adults, Lymphoma, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoid Leukemia, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Daratumumab

Eligibility

Locations

  • University of California not yet accepting patients
    Los Angeles California 90095 United States
  • University of California not yet accepting patients
    San Francisco California 94143 United States
  • Loma Linda University Children's Hospital accepting new patients
    Loma Linda California 92354 United States
  • Riley Children's Hospital accepting new patients
    Indianapolis Indiana 46202 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
New York Medical College
ID
NCT04972942
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated