drugset / Trial / NCT00866346

PR1-Specific Cytotoxic T-Lymphocyte Infusion With Recurrent Chronic Myelogenous Leukemia (CML) After Allogeneic Hematopoietic Transplantation

NCT00866346 ↗

Phase 1 Withdrawn M.D. Anderson Cancer Center
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

EvaluationDrugModalityDoseRoute
Subject PR1-primed lymphocyte Cell therapy 1e+06 cells/kg Other