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| Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068523 |
Purpose
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Ultraviolet-B light therapy given before and after allogeneic stem cell transplantation may help prevent this from happening.
PURPOSE: Clinical trial to study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies.
| Condition | Intervention |
|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: methylprednisolone Procedure: UV light therapy Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma |
| Drug Information available for: | Cyclophosphamide Methylprednisolone Fludarabine Fludarabine monophosphate Cyclosporine Cyclosporin |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies |
| Study Start Date: | June 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE:
Donor lymphocyte infusion is performed per institutional guidelines for patients in whom emerging donor chimerism post allogeneic PBSC transplantation is not progressing (consistently below 50% during first 3 months), for whom donor chimerism is receding (to below 25%) despite cessation of cyclosporine, or who relapse within 24 months after allografting.
Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months.
PROJECTED ACCRUAL: A total of 23-36 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of any of the following hematologic malignancies:
Acute myeloid leukemia (AML) meeting any of the following criteria:
First complete remission with high-risk karyotype
Acute lymphoblastic leukemia meeting any of the following criteria:
Chronic myelogenous leukemia meeting any of the following criteria:
Accelerated phase or blast crisis
Myelodysplastic syndromes meeting any of the following criteria:
Non-Hodgkin's lymphoma or Hodgkin's lymphoma meeting any of the following criteria:
Recurrent disease after autologous stem cell transplantation
Multiple myeloma meeting either of the following criteria:
Chronic lymphocytic leukemia (CLL) meeting all of the following criteria:
Myeloproliferative disorders, including myelofibrosis
Must meet 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Ohio | |||||
| Ireland Cancer Center | |||||
| Cleveland, Ohio, United States, 44106 | |||||
| Ireland Cancer Center |
| National Cancer Institute (NCI) |
| Principal Investigator: | Omer N. Koc, MD | Case Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000327713, CWRU-ICC-7Y02 |
| First Received: | September 10, 2003 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068523 |
| Health Authority: | United States: Federal Government |
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