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

2014-08-27 03:56:01 | BioPortfolio

Summary

Primary Objectives: To evaluate response rates of acute or chronic GVHD following CD8 depleted DLI in patients with CMML, CLL, NHL, MM and 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.

Description

Primary Objectives: To evaluate response rates of acute or chronic GVHD following CD8 depleted DLI in patients with CMML, CLL, NHL, MM and 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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Chronic Myelogenous Leukemia

Intervention

CD8 Depleted Donor Lymphocyte

Location

MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Terminated

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:01-0400

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Medical and Biotech [MESH] Definitions

Clonal hematopoetic disorder caused by an acquired genetic defect in PLURIPOTENT STEM CELLS. It starts in MYELOID CELLS of the bone marrow, invades the blood and then other organs. The condition progresses from a stable, more indolent, chronic phase (LEUKEMIA, MYELOID, CHRONIC PHASE) lasting up to 7 years, to an advanced phase composed of an accelerated phase (LEUKEMIA, MYELOID, ACCELERATED PHASE) and BLAST CRISIS.

An aberrant form of human CHROMOSOME 22 characterized by translocation of the distal end of chromosome 9 from 9q34, to the long arm of chromosome 22 at 22q11. It is present in the bone marrow cells of 80 to 90 per cent of patients with chronic myelocytic leukemia (LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE).

Retrovirus-associated DNA sequences (abl) originally isolated from the Abelson murine leukemia virus (Ab-MuLV). The proto-oncogene abl (c-abl) codes for a protein that is a member of the tyrosine kinase family. The human c-abl gene is located at 9q34.1 on the long arm of chromosome 9. It is activated by translocation to bcr on chromosome 22 in chronic myelogenous leukemia.

A chronic leukemia characterized by a large number of circulating prolymphocytes. It can arise spontaneously or as a consequence of transformation of CHRONIC LYMPHOCYTIC LEUKEMIA.

An advanced phase of chronic myelogenous leukemia, characterized by a rapid increase in the proportion of immature white blood cells (blasts) in the blood and bone marrow to greater than 30%.

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