Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 39
SponsorNew York Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Daratumumab
DrugTotal 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: 1. Induction: DARA IV weekly x 8 doses (Weeks 1-8) 2. Consolidation: DARA every 2 weeks x 8 doses (Weeks 9-24) 3. Maintenance: DARA every 4 weeks (Stop at Day +270)
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: InterventionalOther 1 intervention
Trial outcomes
Primary outcomes
1
Patients with dose limiting toxicity (per CTCAE v.5)
occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is probably, or definitely related to daratumumab
Time frame
60 daysSecondary outcomes
1
Relapse free survival
To measure relapse free survival in patients post HCT and daratumumab
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov