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Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT00068523
Recruitment Status : Completed
First Posted : September 11, 2003
Last Update Posted : July 27, 2020
Sponsor:
Information provided by:
Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE September 10, 2003
First Posted Date  ICMJE September 11, 2003
Last Update Posted Date July 27, 2020
Study Start Date  ICMJE June 2003
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2010)
Study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies. [ Time Frame: Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months. ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
Official Title  ICMJE Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
Intervention  ICMJE
  • Biological: anti-thymocyte globulin
    anti-thymocyte globulin IV over 4 hours on days -2 to -1
  • Drug: cyclophosphamide
    cyclophosphamide IV over 1 hour on days -3 to -2
  • Drug: cyclosporine
    oral cyclosporine on days -1 to 100
  • Drug: fludarabine phosphate
    fludarabine IV over 30 minutes on days -8 to -4
  • Drug: methylprednisolone
    methylprednisolone (oral or IV) on days 5-15
  • Procedure: UV light therapy
    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.
  • Procedure: allogeneic bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
    Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2010)
10
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

        • Translocations t(15;17) allowed only if failed first-line induction therapy OR molecular evidence of persistent disease exists
        • Translocations t(8;21) and inv(16) allowed only if failed first-line induction therapy
      • Second or subsequent complete remission
      • Minimal residual disease*
    • Acute lymphoblastic leukemia meeting any of the following criteria:

      • Failed induction therapy and has minimal residual disease* by salvage therapy
      • First complete remission with high-risk karyotype (e.g., t[4;11] or t[9;22])
      • Relapsed disease allowed provided a second or subsequent complete remission or minimal residual disease* is achieved
    • 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

        • Blast crisis allowed after reinduction chemotherapy places disease in chronic phase
    • Myelodysplastic syndromes meeting any of the following criteria:

      • Refractory to medical management
      • Cytogenetic abnormalities predictive of transformation into acute leukemia, including 5q-, 7q-, monosomy 7 and trisomy 8, or evidence of evolution to AML (e.g., refractory anemia with excess blasts (RAEB) or RAEB in transformation)
    • 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

        • Must be at least 3 months posttransplantation
      • Cyclin D1+ mantle cell lymphoma allowed after induction therapy and in first remission
    • Multiple myeloma meeting either of the following criteria:

      • Refractory or relapsed disease
      • Residual disease after autologous transplantation
    • Chronic lymphocytic leukemia (CLL) meeting all of the following criteria:

      • Peripheral blood absolute lymphocyte count greater than 5,000/mm^3
      • Small to moderate size lymphocytes and less than 55% pro-lymphocytes, atypical lymphocytes, or lymphoblasts morphologically
      • B-cell or T-cell
    • Myeloproliferative disorders, including myelofibrosis

      • Philadelphia negative
  • 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:

    • At least 55 years of age at time of transplantation
    • Received extensive prior therapy (i.e., more than 1 year of alkylator therapy or more than 2 different prior salvage regimens) or stem cell transplantation with myeloablative conditioning (either autologous or allogeneic)
    • Presenting with comorbid condition (e.g., abnormal cardiac, pulmonary, or renal function and/or prior life-threatening infection) that precludes eligibility for enrollment in allogeneic transplantation protocols with full ablation conditioning
  • 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

  • See Disease Characteristics
  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • ALT/AST no greater than 4 times normal

Renal

  • See Disease Characteristics
  • Creatinine less than 2.0 mg/dL OR
  • Creatinine clearance at least 50 mL/min

Cardiovascular

  • See Disease Characteristics
  • Normal cardiac function by echocardiogram or radionuclide scan
  • Shortening fraction or ejection fraction at least 40% of normal

Pulmonary

  • See Disease Characteristics
  • DLCO at least 60%
  • FEV_1 greater than 50% of predicted
  • Pulse oximetry greater than 85%

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No uncontrolled active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • At least 2 weeks since prior biologic response modifiers, signal transduction inhibitors, or monoclonal antibodies

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior systemic conventional chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Recovered from prior therapy
  • No concurrent sun block/sunscreen or any cosmetic that may act as a sunscreen (e.g., lotion with SPF) on the days of scheduled ultraviolet-B light therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00068523
Other Study ID Numbers  ICMJE ICC7Y02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Omer N. Koc, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Omer N. Koc, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP