drugset / Trial / NCT00038818

CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation

NCT00038818 ↗

NaSingle-groupOpen-labelTreatment

Summary

Primary Objectives: To evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple Myeloma (MM) and Hodgkin's Lymphoma (HD). Secondary Objectives: * To evaluate safety and treatment related mortality after CD8 depleted DLI. * To evaluate the time to onset of GVHD following DLI and response to GVHD treatment. * To evaluate the incidence and timing of pancytopenia following DLI. * To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM). * To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions. * To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells.

Timeline

Start
2001-05
Primary completion
2002-12
Completion
2002-12

Outcome

Outcome not reported

Stopped (Enrollment): “Low accrual.”

Drugs

EvaluationDrugModalityDoseRoute
Subject CD8 Depleted Donor Lymphocyte Cell therapy — —