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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological | anti-thymocyte globulin IV over 4 hours on days -2 to -1 | ||
| cyclophosphamide | Drug | cyclophosphamide IV over 1 hour on days -3 to -2 | ||
| cyclosporine | Drug | oral cyclosporine on days -1 to 100 | ||
| fludarabine phosphate | Drug | fludarabine IV over 30 minutes on days -8 to -4 | ||
| methylprednisolone | Drug | methylprednisolone (oral or IV) on days 5-15 | ||
| UV light therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies. | Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months. |
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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
Second or subsequent complete remission
Minimal residual disease*
Acute lymphoblastic leukemia meeting any of the following criteria:
Chronic myelogenous leukemia meeting any of the following criteria:
Persistent or relapsed disease after 1 year of imatinib mesylate therapy
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:
Beyond first complete remission or failed primary induction therapy and demonstrated sensitivity to therapy during the 6 months before transplantation
Recurrent disease after autologous stem cell transplantation
Cyclin D1+ mantle cell lymphoma allowed after induction therapy and in first remission
Multiple myeloma meeting either of the following criteria:
Chronic lymphocytic leukemia (CLL) meeting all of the following criteria:
Myeloproliferative disorders, including myelofibrosis
Availability of a HLA-A, B, and DR identical family donor OR HLA-A, B, and DR genetically matched unrelated donor
Must meet 1 of the following criteria:
No active CNS disease NOTE: *Defined as having no circulating blasts, absolute neutrophil count greater than 1,000/mm3 and less than 10% blasts in bone marrow at least 3 weeks after last systemic chemotherapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Omer N. Koc, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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Patients undergo ultraviolet-B (UVB) light therapy every other day between days -10 and -2 for a total of 3 days. Posttransplantation UVB light therapy: Following PBSC transplantation, patients undergo UVB light therapy twice weekly on week 1 (at least 1 day apart) and three times weekly on weeks 2-4.
| allogeneic bone marrow transplantation | Procedure |
| peripheral blood stem cell transplantation | Procedure | Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0. |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D001752 | Blast Crisis |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D002051 | Burkitt Lymphoma |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D055728 | Primary Myelofibrosis |
| D054066 | Leukemia, Large Granular Lymphocytic |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D006689 | Hodgkin Disease |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D007945 | Leukemia, Lymphoid |
| D015448 | Leukemia, B-Cell |
| D016393 | Lymphoma, B-Cell |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D015458 | Leukemia, T-Cell |
| D016399 | Lymphoma, T-Cell |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D003520 | Cyclophosphamide |
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D008775 | Methylprednisolone |
| D014467 | Ultraviolet Therapy |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D010789 | Phototherapy |
| D013812 | Therapeutics |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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