CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
NCT ID: NCT00038818
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2001-05-31
2002-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CD8 DLI
CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)
CD8 Depleted Donor Lymphocyte
Interventions
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CD8 Depleted Donor Lymphocyte
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Eligix
UNKNOWN
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Richard Champlin, MD, BS
Role: PRINCIPAL_INVESTIGATOR
UT MD Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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ID00-335
Identifier Type: -
Identifier Source: org_study_id