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Clinical trialNCT04972942RecruitingPhase 1Interventional

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

SponsorNew York Medical CollegeEnrollment30T-Cell Acute Lymphoblastic LymphomaT-cell Acute Lymphoblastic Leukemia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

16 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Phoenix Children'S Hospital

    Phoeniz, Arizona, United States

    Not, yet, recruiting
  • Loma Linda University Children'S Hospital

    Loma Linda, California, United States

    Recruiting
  • University of California

    Los Angeles, California, United States

    Not, yet, recruiting
  • University of California

    San Francisco, California, United States

    Recruiting
  • Children'S Hospital Colordao

    Aurora, Colorado, United States

    Not, yet, recruiting
  • Children'S National Medical Center

    Washington D.C., District of Columbia, United States

    Not, yet, recruiting
  • University of Florida

    Gainsville, Florida, United States

    Recruiting
  • John Hopkins All Children'S Hospital

    St. Petersburg, Florida, United States

    Not, yet, recruiting
  • Riley Children'S Hospital

    Indianapolis, Indiana, United States

    Recruiting
  • Boston Children'S Hospital

    Boston, Massachusetts, United States

    Recruiting
  • Helen Devos Children'S Hospital

    Grand Rapids, Michigan, United States

    Recruiting
  • New York Medical College

    Vallhala, New York, United States

    Recruiting
  • Nationwide Children'S Hosptial

    Columbus, Ohio, United States

    Not, yet, recruiting
  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Recruiting
  • Md Anderson Cancer Center

    Houston, Texas, United States

    Not, yet, recruiting
  • Medical College of Wisconsin

    Milwaukee, Wisconsin, United States

    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
22 May 2023
Primary completion
30 Sept 2027
Completion
30 Sept 2028
Last update posted
15 Apr 2026
Registered enrollment
30
Registry id
NCT04972942

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.