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Immunotherapy in Treating Patients Who Are Undergoing Bone Marrow or Peripheral Stem Cell Transplantation



Immunotherapy in Treating Patients Who Are Undergoing Bone Marrow or Peripheral Stem Cell Transplantation

For Condition: Lymphoma,Leukemia,Multiple Myeloma
Status: No longer recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 12 Years/60 Years
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StanRiddell,  Study Chair,  Fred Hutchinson Cancer Research Center

Fred Hutchinson Cancer Research Center
Seattle,  Washington,  98109
United States
 


Additional Information:
Study ID Numbers:  CDR0000064307;  FHCRC-1011.01,NCI-V95-0702
Study Start Date: June 1995
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002673

Other Leukemia Studies:
1. Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally

2. Comparing Treatments for Multiple Myeloma

3. Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers

4. Thalidomide-Dexamethasone for Multiple Myeloma

5. Pyroxamide in Treating Patients With Advanced Cancer

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