Clinical trial
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)
Name
NYMC-598
Description
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.
Trial arms
Trial start
2023-05-22
Estimated PCD
2027-09-01
Trial end
2028-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Daratumumab
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:
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)
Arms:
Interventional
Other names:
Darzalex®
Size
30
Primary endpoint
Patients with dose limiting toxicity (per CTCAE v.5)
60 days
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
* 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1: 3 dose levels to determine safety. Followed by dose expansion cohort.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-07-03
1 organization
1 product
2 indications
Organization
New York Medical CollegeProduct
DaratumumabIndication
T-cell Acute Lymphoblastic LeukemiaIndication
T-Cell Acute Lymphoblastic Lymphoma