Trial | NCT00038818  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    3
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.
Study Started
May 31
2001
Primary Completion
Dec 31
2002
Study Completion
Dec 31
2002
Last Update
Aug 23
2012
Estimate

Biological CD8 Depleted Donor Lymphocyte

CD8 DLI Experimental

CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)

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
No Results Posted