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Daratumumab in MRD-Positive T-Cell Acute Lymphoblastic Leukemia
NCT06570915Phase 2
Key facts
- Status
- Withdrawn
- Start
- Dec 2025
- Primary completion
- Sep 2027
- Sponsor
- Institute of Hematology and Blood Diseases Hospital
- Modality
- Recombinant Proteins and Enzymes, Monoclonal Antibodies
- Drugs
- daratumumab
- Conditions
- t-cell acute lymphoblastic leukemia (T-ALL)
01
Overview
Phase 2, open-label, single-arm trial of daratumumab in t-cell acute lymphoblastic leukemia (T-ALL), sponsored by Institute of Hematology and Blood Diseases Hospital. Primary endpoint: Rate of conversion from MRD+ to MRD- by flow cytometry at 28 days. Planned start Dec 2025; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Daratumumab
Daratumumab administered once a week at a dose of 16 mg/kg for a total of 4 times in one cycle. Up to two cycles.
03
Who it enrols
Adult patients with newly diagnosed or relapsed T-cell acute lymphoblastic leukemia who achieved CR but are MRD positive (>=0.01%) after chemotherapy, with CD38 positive tumor cells and adequate organ function.
04
Endpoints
Primary
Rate of conversion from MRD+ to MRD- by flow cytometry
Secondary
Overall Survival
Disease-Free Survival
Cumulative Incidence of Relapse
Duration of MRD-negative response
Rate of conversion from MRD+ to MRD- by NGS
30-day mortality
60-day mortality
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