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

Recruiting now · Phase 1

Conditions studied: T-cell Acute Lymphoblastic Leukemia, T-Cell Acute Lymphoblastic Lymphoma

In brief

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.

Key facts

Study ID

NCT04972942

Run by

New York Medical College

People needed

30

Starts

2023-05-22

Expected to finish

2028-09-01

Last updated by the study team

2026-04-15

Who can join

Age: any, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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