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Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation



Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation

For Condition: Plasma Cell Neoplasm,Aplastic Anemia,Graft Versus Host Disease,Leukemia,Lymphoma,Solid Tumor
Status: No longer recruiting
Sponsor(s): Sidney Kimmel Cancer Center ,
Synopsis: RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Stem cells that have been treated in the laboratory to remove lymphocytes may prevent this from happening. PURPOSE: Clinical trial to prevent graft-versus-host disease in patients undergoing bone marrow transplantation.
Details: OBJECTIVES: - Determine whether stem cell augmented, elutriated grafts prevent graft versus host disease in patients undergoing allogeneic bone marrow transplantation. OUTLINE: Patients receive elutriated CD34+ augmented donor bone marrow on day 0. Bone marrow samples are obtained before day 100, around 6 months, and 1 year after transplant. PROJECTED ACCRUAL: Not specified
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of one the following: - Acute myelogenous leukemia in CR1, ER1, CR2, ER2, CR3 - Acute lymphocytic leukemia in CR1, ER1, CR2, ER2, CR3 - Non-Hodgkin's lymphoma - Hodgkin's lymphoma - Multiple myeloma with no more than 12 months of prior alkylator based chemotherapy - Myelodysplastic syndrome (MDS) - Acute leukemia arising out of MDS - Primary resistant acute leukemia - Chronic myelomonocytic leukemia - Aplastic anemia (40 years of age and over) - Solid tumor malignancy (germ cell, sarcoma, breast, etc.) - Genetic disorders or inborn errors of metabolism as defined by preparative regimen protocol - Chronic myelogenous leukemia - Must meet all inclusion criteria specified by the respective preparative regimen protocol - No aplastic anemia under 40 years of age or myelofibrosis PATIENT CHARACTERISTICS: Age: - 0.5 to 65 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior red blood cell or platelet transfusions from a sibling donor Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RichardJones,  Study Chair,  Sidney Kimmel Cancer Center

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore,  Maryland,  21231-2410
United States
 


Additional Information:
Study ID Numbers:
  CDR0000066589;  JHOC-97021903,JHOC-J9711,NCI-V98-1460
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003538

Other Graft Versus Host Disease Studies:
1. Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma

2. Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies

3. Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia

4. Visilizumab in Treating Patients With Graft-Versus-Host Disease Following Donor Stem Cell Transplantation

5. Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia

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