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

ClinicalTrials.gov ID: NCT04972942

Public ClinicalTrials.gov record NCT04972942. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 16, 2026, 7:48 PM EDT

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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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04972942
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: New York Medical College; Other
Enrollment: 30 participants

Conditions and interventions

Conditions

Interventions

Daratumumab Drug

Drug

Eligibility (public fields only)

Age range: Up to 39 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 22, 2023 (Actual)
Primary completion: Sep 2027 (Estimated)
Completion: Sep 2028 (Estimated)
Last update posted: Sep 11, 2026

2023 – 2028

United States locations

U.S. sites: 16
U.S. states: 13
U.S. cities: 16

Facility	City	State	ZIP	Site status
Phoenix Children's Hospital	Phoeniz	Arizona	85016	Not yet recruiting
Loma Linda University Children's Hospital	Loma Linda	California	92354	Recruiting
University of California	Los Angeles	California	90095	Not yet recruiting
University of California	San Francisco	California	94143	Recruiting
Children's Hospital Colordao	Aurora	Colorado	80045	Not yet recruiting
Children's National Medical Center	Washington D.C.	District of Columbia	20010	Not yet recruiting
University of Florida	Gainsville	Florida	32608	Recruiting
John Hopkins All Children's Hospital	St. Petersburg	Florida	33701	Not yet recruiting
Riley Children's Hospital	Indianapolis	Indiana	46202	Recruiting
Boston Children's Hospital	Boston	Massachusetts	02115	Recruiting
Helen DeVos Children's Hospital	Grand Rapids	Michigan	49503	Recruiting
New York Medical College	Vallhala	New York	10595	Recruiting
Nationwide Children's Hosptial	Columbus	Ohio	43205	Not yet recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
MD Anderson Cancer Center	Houston	Texas	77030	Not yet recruiting
Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04972942, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 11, 2026 · Synced Oct 16, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04972942 live on ClinicalTrials.gov.

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