Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
Condition: Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Hematologic Neoplasms; Plasmacytoma; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety of ultraviolet-B light therapy and allogeneic peripheral blood stem
           cell transplantation in patients with hematologic malignancies by demonstrating 100-day
           mortality no greater than 15% and 1-year mortality no greater than 40%.

        -  Determine the frequency of treatment-related toxicity leading to death and frequency of
           disease relapse resulting in death in patients treated with this regimen.

        -  Determine the incidence and severity of acute and chronic graft-versus-host disease in
           patients treated with this regimen.

      Secondary

        -  Determine the rates of donor allogeneic hematologic engraftment in patients treated with
           this regimen.

        -  Determine the rate and quality of immune reconstitution in the peripheral blood and the
           composition of immune cells in the skin before and after transplantation in these
           patients.

        -  Determine the event-free and overall survival of patients treated with this regimen.

      OUTLINE:

        -  Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4
           and cyclophosphamide IV over 1 hour on days -3 to -2. Patients also receive
           anti-thymocyte globulin IV over 4 hours on days -2 to -1. Patients undergo ultraviolet-B
           (UVB) light therapy every other day between days -10 and -2 for a total of 3 days.

        -  Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC
           transplantation on day 0.

        -  Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine on days -1 to
           100 and methylprednisolone (oral or IV) on days 5-15.

        -  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.

      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.
    

Intervention name(s): anti-thymocyte globulin; cyclophosphamide; cyclosporine; fludarabine phosphate; methylprednisolone; UV light therapy; allogeneic bone marrow transplantation; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure; Procedure; Procedure
Intervention description(s): anti-thymocyte globulin IV over 4 hours on days -2 to -1; cyclophosphamide IV over 1 hour on days -3 to -2; oral cyclosporine on days -1 to 100; fludarabine IV over 30 minutes on days -8 to -4; methylprednisolone (oral or IV) on days 5-15; 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 peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0.
Intervention MeSH terms: Cyclosporine; Methylprednisolone; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Cyclosporins; Antilymphocyte Serum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory multiple myeloma; accelerated phase chronic myelogenous leukemia; adult acute lymphoblastic leukemia in remission; adult acute myeloid leukemia in remission; blastic phase chronic myelogenous leukemia; recurrent adult acute lymphoblastic leukemia; recurrent adult acute myeloid leukemia; refractory chronic lymphocytic leukemia; relapsing chronic myelogenous leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult Burkitt lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; refractory anemia with excess blasts in transformation; refractory anemia with excess blasts; secondary myelodysplastic syndromes; Philadelphia chromosome negative chronic myelogenous leukemia; chronic idiopathic myelofibrosis; B-cell chronic lymphocytic leukemia; T-cell large granular lymphocyte leukemia; chronic phase chronic myelogenous leukemia; recurrent adult Hodgkin lymphoma; recurrent adult T-cell leukemia/lymphoma; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; recurrent cutaneous T-cell non-Hodgkin lymphoma; recurrent mycosis fungoides/Sezary syndrome; secondary acute myeloid leukemia; atypical chronic myeloid leukemia; myelodysplastic/myeloproliferative disease, unclassifiable; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12)