RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: New York Medical College • ClinicalTrials.gov ID: NCT04972942

Registry updated: 2026-09-11

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Description

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.

Interventions

Daratumumab (Drug)
Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor. Daratumumab (DARA) treatment post-HCT Phase 1: 3 dose levels to determine safety (15 patients) Dose expansion: 1. Induction: DARA IV weekly x 8 doses (Weeks 1-8) 2. Consolidation: DARA every 2 weeks x 8 doses (Weeks 9-24) 3. Maintenance: DARA every 4 weeks (Stop at Day +270)

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * May not have had a prior autologous or allogenic stem cell transplant * 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 * Must not be pregnant or actively breast feeding * Seropositive for HIV, hepatitis B or hepatitis C * COPD * Asthma * Clinically significant cardiac disease

Conditions

T-cell Acute Lymphoblastic Leukemia T-Cell Acute Lymphoblastic Lymphoma

Locations

Phoenix Children's Hospital — Phoeniz, Arizona, United States
Loma Linda University Children's Hospital — Loma Linda, California, United States
University of California — Los Angeles, California, United States
University of California — San Francisco, California, United States
Children's Hospital Colordao — Aurora, Colorado, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
University of Florida — Gainsville, Florida, United States
John Hopkins All Children's Hospital — St. Petersburg, Florida, United States
Riley Children's Hospital — Indianapolis, Indiana, United States
Boston Children's Hospital — Boston, Massachusetts, United States
Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
New York Medical College — Vallhala, New York, United States
Nationwide Children's Hosptial — Columbus, Ohio, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center — Houston, Texas, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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