Multiple Myeloma Clinical Trial
Official title:
CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation
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.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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