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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Myelogenous Leukemia, Multiple Myeloma, Non Hodgkin's Lymphoma, Hodgkin's Disease, Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Biological: CD8 Depleted Donor Lymphocyte


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD8 DLI<br>CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) | Biological: CD8 Depleted Donor Lymphocyte<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Response Rates of Acute or Chronic GVHD |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CML, MM, NHL, HD, CLL, CD8 Depleted, Donor Lymphocyte