drugset / Trial / NCT00473551

Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Indolent Lymphoid Malignancies

NCT00473551

Phase 1 Terminated 4 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: 1\. To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes, defined as the dose which achieve engraftment without severe GVHD (graft-vs-host disease) at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells. Secondary Objective: 1\. Toxicity, response rate, time to progression and overall survival.

Timeline

Start
2007-05
Primary completion
2009-11
Completion
2009-11

Drugs

EvaluationDrugModalityDoseRoute
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 10 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Background Fludarabine Small molecule 40 mg/m2 Intravenous
Background Rituximab Monoclonal antibody 1000 mg/m2 Intravenous
Background Sirolimus Small molecule 2 mg Oral