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Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA with High Risk T-Cell ALL & Lymphoma
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT04972942.
