CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Eligix
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038818

Purpose

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.

Condition	Intervention
Chronic Myelogenous Leukemia Multiple Myeloma Non Hodgkin's Lymphoma Hodgkin's Disease Chronic Lymphocytic Leukemia	Procedure: CD8 Depleted Donor Lymphocyte

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Hodgkin Disease Leukemia Lymphoma Multiple Myeloma

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Patient Response Rates of Acute or Chronic GVHD [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	3
Study Start Date:	May 2001
Study Completion Date:	December 2002
Primary Completion Date:	December 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CD8 DLI	Procedure: CD8 Depleted Donor Lymphocyte

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients of any age who have previously undergone allogeneic hematopoietic transplantation and have evidence of donor cell engraftment (>20% donor cell within three months of study entry)
Expected survival >4 weeks
CML patients with molecular, cytogenetic or hematologic relapse following allogeneic transplantation
1. Molecular relapse- patients are eligible if bcr/abl is detectable at any time after day 180 post-allogeneic transplantation or if a negative bcr/abl PCR test was documented post-transplantation and the bcr/abl test is now positive by consecutive PCR determinations at least 4 weeks apart.
2. Cytogenetic relapse-patients are eligible if standard cytogenetics demonstrate >10% t (9,22) positive cells greater than 60 days after myeloablative transplantation or 10% t (9,22) positive cells greater than 100 days after nonmyeloablative transplantation.
CML patients with accelerated phase or blast crisis following allogeneic transplantation
Patients with CLL, NHL, MM, or HD who have evidence of disease relapse or persistent disease at 60 days post-allo BMT and/or:
1. MM- patients with a rising M-protein is detectable at 180 days post-transplant
2. NHL - patients with molecular evidence of disease (bcl-2, t (4,11), etc.) at 180 days post transplant
3. CLL, NHL or HD - patients with clear cut evidence of tumor growth at any time post-transplant are eligible
Patients undergoing an HLA -identical or 5/6 antigen match transplant from a related or unrelated donor
Patient's original donor must be available for lymphocyte donation
There must be no evidence of active acute or graft-versus-host disease and patients should be off all immunosuppressive agents for, at least, two weeks prior to DLI. Patients on stable dose of methylprednisolone (<16 mg/d) without evidence of active GVHD are also eligible.
Patients must have a Zubrod PS<2 (see appendix 7), Cr<2.5, bilirubin <3, and transaminases (SGPT, SGOT) <4x normal
Patient must be able to sign informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038818

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Eligix

Investigators

Principal Investigator:

Richard Champlin, MD, BS

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Richard Champlin, MD,BS / Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038818 History of Changes
Other Study ID Numbers:	ID00-335
Study First Received:	June 5, 2002
Last Updated:	October 25, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

CML
MM
NHL
HD

CLL
CD8 Depleted
Donor Lymphocyte

Additional relevant MeSH terms:

Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders

Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on February 09, 2012