RecruitingPhase IEN originalLeukemia

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek 0-39 lat
  • •Białaczka T-komórkowa w drugiej lub kolejnej remisji (nie więcej niż 5% komórek nowotworowych) lub chłoniak T w pełnej remisji po ponownym leczeniu
  • •Planowane przeszczepienie komórek krwiotwórczych od dawcy
  • •Ogólny stan zdrowia pozwalający na leczenie (≥60%)
  • •W pełni wyzdrowiały po wcześniejszych chemioterapiach lub radioterapii
  • •Prawidłowa funkcja organów wewnętrznych
  • •Podpisana świadoma zgoda na udział w badaniu

✗ Disqualifies

  • •Wcześniejsze przeszczepienie komórek krwiotwórczych
  • •Niekontrolowana infekcja w momencie włączenia do badania
  • •Alergia na składniki leku daratumumab lub podobnych produktów
  • •Ciąża lub karmienie piersią
  • •Dodatni wynik na HIV, zapalenie wątroby B lub C
  • •Przewlekła obturacyjna choroba płuc (POChP)
  • •Astma
  • •Poważna choroba serca

Simplified criteria — AI translation

Trial details

Maximum age
39 Years
Last updated (source)
September 11, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (16)

Phoenix Children's Hospital

Phoeniz, United States

Loma Linda University Children's Hospital

Loma Linda, United States

University of California

Los Angeles, United States

University of California

San Francisco, United States

Children's Hospital Colordao

Aurora, United States

Children's National Medical Center

Washington D.C., United States

University of Florida

Gainsville, United States

John Hopkins All Children's Hospital

St. Petersburg, United States

Riley Children's Hospital

Indianapolis, United States

Boston Children's Hospital

Boston, United States

Helen DeVos Children's Hospital

Grand Rapids, United States

New York Medical College

Vallhala, United States

Nationwide Children's Hosptial

Columbus, United States

Children's Hospital of Philadelphia

Philadelphia, United States

MD Anderson Cancer Center

Houston, United States

Medical College of Wisconsin

Milwaukee, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/12/2026.

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