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Clinical Trial: Immunotherapy in Treating Patients Who Are Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
This study is no longer recruiting patients.
Purpose
RATIONALE: White blood cells from donors who have been exposed to cytomegalovirus may be able to help prevent this infection from occurring in patients who are undergoing bone marrow or peripheral stem cell transplantation. PURPOSE: Phase II trial to study the effectiveness of donated white blood cells to prevent cytomegalovirus infection in patients who are undergoing bone marrow or peripheral stem cell transplantation.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Lymphoma Leukemia Multiple Myeloma | Procedure: CMV-exposed white blood cells for transplant | Phase II |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma; Multiple Myeloma
Study Type: Interventional
Study Design: Educational/Counseling/Training
Official Title: Phase II Study of Cellular Adoptive Immunotherapy as Prophylaxis for Cytomegalovirus Disease in Allogeneic Bone Marrow Transplant Recipients
Study start: June 1995
OBJECTIVES: I. Evaluate whether cytomegalovirus (CMV) antigenemia is preventable in allogeneic marrow recipients who are CMV-positive by infusing donor-derived CD8-positive (CD8+), CMV-specific, major histocompatibility complex (MHC) class I-restricted cytotoxic T-lymphocyte (CTL) clones. II. Assess whether adoptive immunotherapy with these CMV-specific CTL clones prevents CMV viremia and disease in CMV-seropositive allogeneic marrow recipients. III. Evaluate whether the transfer of CD4+ CMV-specific T-helper (Th) cells to patients with deficient responses at day 80 can reconstitute CD4+ Th-cell activity and augment adoptively transferred CD8+ CTL.
PROTOCOL OUTLINE: The following acronyms are used: CMV Cytomegalovirus CTL Cytotoxic T lymphocytes GVHD Graft-vs.-host disease MHC Major histocompatibility complex Th T helper CMV Prophylaxis. Allogeneic CD8+, CMV-specific, MHC class I-restricted CTL; followed, as indicated, by allogeneic CMV-specific CD4+ Th cells.
PROJECTED ACCRUAL: 30 patients will be accrued over 12-18 months. The study will close if the incidence of CMV disease exceeds 20% or the incidence of CMV antigenemia exceeds 40%.
Eligibility
Ages Eligible for Study: 12 Years - 60 Years
Criteria
PROTOCOL ENTRY CRITERIA:
- CMV seropositive patients aged 12 to 60
- Malignancy requiring allogeneic bone marrow or peripheral blood stem cell transplantation meeting the following criteria at day 28 post-transplant: No documented graft rejection ANC at least 500; No intervening CMV antigenemia (greater than 5 cells/slide) or CMV disease; No grade III/IV GVHD in 2 or more organs prior to day 21 unless responsive to treatment by day 28 BC-3 therapy for acute GVHD completed prior to T-cell therapy; No grade III organ toxicity
- Donor requirements: HLA-identical relative CMV seropositive; Over age 16; Not HTLV-1 or HIV seropositive; Adequate peripheral veins to permit leukapheresis; Skin biopsy specimen required at least 4 weeks prior to transplant
Location Information
Stan Riddell, Study Chair, Fred Hutchinson Cancer Research Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002673
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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