drugset / Trial / NCT00866346
PR1-Specific Cytotoxic T-Lymphocyte Infusion With Recurrent Chronic Myelogenous Leukemia (CML) After Allogeneic Hematopoietic Transplantation
NaSingle-groupOpen-labelTreatment
Summary
Primary Objective: To determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL) as treatment for relapsed or persistent chronic myelogenous leukemia (CML) after allogeneic hematopoietic transplantation from an HLA-matched related or unrelated donor. Secondary Objectives: 1. To evaluate the immunological response following PR1-CTL treatment 2. To evaluate the clinical efficacy by determining clinical, cytogenetic and molecular response rates within 6 months
Timeline
- Start
- 2008-03
- Primary completion
- 2015-03
- Completion
- —
Outcome
Outcome not reported
Stopped (Enrollment): “Study failed to accrue any patients due to regulatory issues with PR1 vaccine and T cell production.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PR1-primed lymphocyte | Cell therapy | 1e+06 cells/kg | Other |