Targeted immunotherapy for high-risk T-cell leukemia and lymphoma in young patients
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)
This study is testing a new treatment called daratumumab for young patients with high-risk T-cell leukemia and lymphoma to see if it is safe and helps improve their outcomes after a stem cell transplant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | N/A to 39 Years |
| Sex | All |
| Sponsor | New York Medical College Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, daratumumab |
| Locations | 16 sites (Phoeniz, Arizona and 15 other locations) |
| Trial ID | NCT04972942 on ClinicalTrials.gov |
What this trial studies
This Phase I trial evaluates the safety of daratumumab (DARA) administered after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) in children, adolescents, and young adults with high-risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). The study includes pre- and post-HCT assessments of minimal residual disease (MRD) and immune reconstitution to correlate these factors with patient outcomes. Participants will receive DARA in a structured treatment schedule, including induction, consolidation, and maintenance phases. The trial aims to identify the optimal dosing and safety profile of DARA in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are children, adolescents, and young adults aged 0-39 years with high-risk T-cell ALL or relapsed T-cell lymphoma who are eligible for allogeneic stem cell transplantation.
Not a fit: Patients with uncontrolled infections, prior stem cell transplants, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for young patients with high-risk T-cell leukemia and lymphoma.
How similar studies have performed: While targeted immunotherapy is a growing field, this specific approach combining TBI and DARA in this patient population is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoeniz, Arizona and 15 other locations
- Phoenix Children's Hospital — Phoeniz, Arizona, United States (Not_yet_recruiting)
- Loma Linda University Children's Hospital — Loma Linda, California, United States (Recruiting)
- University of California — Los Angeles, California, United States (Not_yet_recruiting)
- University of California — San Francisco, California, United States (Recruiting)
- Children's Hospital Colordao — Aurora, Colorado, United States (Not_yet_recruiting)
- Children's National Medical Center — Washington D.C., District of Columbia, United States (Not_yet_recruiting)
- University of Florida — Gainsville, Florida, United States (Recruiting)
- John Hopkins All Children's Hospital — St. Petersburg, Florida, United States (Not_yet_recruiting)
- Riley Children's Hospital — Indianapolis, Indiana, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States (Recruiting)
- New York Medical College — Vallhala, New York, United States (Recruiting)
- Nationwide Children's Hosptial — Columbus, Ohio, United States (Not_yet_recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Not_yet_recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Lauren Harrison, RN, MSN
- Email: lauren_harrison@nymc.edu
- Phone: 6172857844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.