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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00038818

Collaborator

Eligix (Other)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myelogenous Leukemia Multiple Myeloma Non Hodgkin's Lymphoma Hodgkin's Disease Chronic Lymphocytic Leukemia	Biological: CD8 Depleted Donor Lymphocyte	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation

Study Start Date :

May 1, 2001

Actual Primary Completion Date :

Dec 1, 2002

Actual Study Completion Date :

Dec 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD8 DLI CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)	Biological: CD8 Depleted Donor Lymphocyte

Arm

Intervention/Treatment

Experimental: CD8 DLI

CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)

Biological: CD8 Depleted Donor Lymphocyte

Outcome Measures

Primary Outcome Measures

Patient Response Rates of Acute or Chronic GVHD [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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