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
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Colordao Coordinator of this site? Confirm its status | Aurora | United States | Not yet recruiting |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Nationwide Children's Hosptial Coordinator of this site? Confirm its status | Columbus | United States | Not yet recruiting |
| University of Florida Coordinator of this site? Confirm its status | Gainsville | United States | Recruiting |
| Helen DeVos Children's Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
| Riley Children's Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Loma Linda University Children's Hospital Coordinator of this site? Confirm its status | Loma Linda | United States | Recruiting |
| University of California Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Not yet recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Phoenix Children's Hospital Coordinator of this site? Confirm its status | Phoeniz | United States | Not yet recruiting |
| University of California Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| John Hopkins All Children's Hospital Coordinator of this site? Confirm its status | St. Petersburg | United States | Not yet recruiting |
| New York Medical College Coordinator of this site? Confirm its status | Vallhala | United States | Recruiting |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.