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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)
Who can join
Up to age 39 · All sexes
Full 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
About the study
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.
What is being tested
- Daratumumab (drug)
Sponsor: New York Medical College · Participants: 30 · Started: May 22, 2023
Contact the study team
- Lauren Harrison, RN, MSN · Phone: 6172857844
- Erin Morris, RN · Phone: 7149645359
Official record on ClinicalTrials.gov — NCT04972942
Locations in the U.S.
| Arizona | Phoenix Children's Hospital, Phoeniz (Not yet recruiting) |
| California | Loma Linda University Children's Hospital, Loma Linda University of California, Los Angeles (Not yet recruiting) University of California, San Francisco |
| Colorado | Children's Hospital Colordao, Aurora (Not yet recruiting) |
| District of Columbia | Children's National Medical Center, Washington D.C. (Not yet recruiting) |
| Florida | University of Florida, Gainsville John Hopkins All Children's Hospital, St. Petersburg (Not yet recruiting) |
| Indiana | Riley Children's Hospital, Indianapolis |
| Massachusetts | Boston Children's Hospital, Boston |
| Michigan | Helen DeVos Children's Hospital, Grand Rapids |
| New York | New York Medical College, Vallhala |
| Ohio | Nationwide Children's Hosptial, Columbus (Not yet recruiting) |
| Pennsylvania | Children's Hospital of Philadelphia, Philadelphia |
| Texas | MD Anderson Cancer Center, Houston (Not yet recruiting) |
| Wisconsin | Medical College of Wisconsin, Milwaukee (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.