Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor.
Daratumumab (DARA) treatment post-HCT:
Phase 1: 3 dose levels to determine safety (15 patients)
Dose expansion cohort (DEC): Further evaluation of PK and PD (correlative studies/exploratory endpoints) to guide future selection of RP2D (15 patients)
Treatment Schedule:
1. Induction: DARA IV weekly x 8 doses (Weeks 1-8)
2. Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24)
3. Maintenance: DARA IV every 4 weeks (Stop at Day +270)
Age
0–39
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma
