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

Primary Purpose

Chronic Myelogenous Leukemia, Multiple Myeloma, Non Hodgkin's Lymphoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CD8 Depleted Donor Lymphocyte
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myelogenous Leukemia focused on measuring CML, MM, NHL, HD, CLL, CD8 Depleted, Donor Lymphocyte

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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. 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: MM- patients with a rising M-protein is detectable at 180 days post-transplant NHL - patients with molecular evidence of disease (bcl-2, t (4,11), etc.) at 180 days post transplant 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

Sites / Locations

  • UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD8 DLI

Arm Description

CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)

Outcomes

Primary Outcome Measures

Patient Response Rates of Acute or Chronic GVHD

Secondary Outcome Measures

Full Information

First Posted
June 5, 2002
Last Updated
August 22, 2012
Sponsor
M.D. Anderson Cancer Center
Collaborators
Eligix
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1. Study Identification

Unique Protocol Identification Number
NCT00038818
Brief Title
CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
Official Title
CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Low accrual.
Study Start Date
May 2001 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Eligix

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia, Multiple Myeloma, Non Hodgkin's Lymphoma, Hodgkin's Disease, Chronic Lymphocytic Leukemia
Keywords
CML, MM, NHL, HD, CLL, CD8 Depleted, Donor Lymphocyte

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD8 DLI
Arm Type
Experimental
Arm Description
CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)
Intervention Type
Biological
Intervention Name(s)
CD8 Depleted Donor Lymphocyte
Primary Outcome Measure Information:
Title
Patient Response Rates of Acute or Chronic GVHD
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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 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. 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: MM- patients with a rising M-protein is detectable at 180 days post-transplant NHL - patients with molecular evidence of disease (bcl-2, t (4,11), etc.) at 180 days post transplant 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Champlin, MD, BS
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

Learn more about this trial

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

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