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NCT04972942RecruitingPhase 1

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

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)

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
30 (estimated)
First submitted
13 Jul 2021
Start date
22 May 2023
Primary completion date
Sept 2027
Lead sponsor
New York Medical College
NCT number
NCT04972942

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 30
  • From 22 May 2023 to the primary completion date, Sept 2027
  • 16 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • May not have had a prior autologous or allogenic stem cell transplant

Other illness

  • May not have uncontrolled, systemic infection at the time of enrollment
  • Known allergies, hypersensitivity, or intolerance to mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients
  • Seropositive for HIV, hepatitis B or hepatitis C
  • Clinically significant cardiac disease

Other

  • Must not be pregnant or actively breast feeding
  • COPD
  • Asthma

Who the study is looking for

  • 0-39yrs
  • T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy (including secondary malignancy)
  • Planned allogeneic stem cell transplantation with donor identified
  • Performance status ≥ 60%
  • Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
  • Meet organ function requirements
  • Signed IRB approved informed consent

Age in the registry: - to 39 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Children's Hospital Colordao
Coordinator of this site? Confirm its status
AuroraUnited StatesNot yet recruiting
Boston Children's Hospital
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BostonUnited StatesRecruiting
Nationwide Children's Hosptial
Coordinator of this site? Confirm its status
ColumbusUnited StatesNot yet recruiting
University of Florida
Coordinator of this site? Confirm its status
GainsvilleUnited StatesRecruiting
Helen DeVos Children's Hospital
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesRecruiting
MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesNot yet recruiting
Riley Children's Hospital
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
Loma Linda University Children's Hospital
Coordinator of this site? Confirm its status
Loma LindaUnited StatesRecruiting
University of California
Coordinator of this site? Confirm its status
Los AngelesUnited StatesNot yet recruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesNot yet recruiting
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesRecruiting
Phoenix Children's Hospital
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PhoenizUnited StatesNot yet recruiting
University of California
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San FranciscoUnited StatesRecruiting
John Hopkins All Children's Hospital
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St. PetersburgUnited StatesNot yet recruiting
New York Medical College
Coordinator of this site? Confirm its status
VallhalaUnited StatesRecruiting
Children's National Medical Center
Coordinator of this site? Confirm its status
Washington D.C.United StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.