Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
Condition: Mycoses; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous; Bone Marrow Transplant Failure; Lymphoma, Non-Hodgkin; Cutaneous T-cell Lymphoma
MeSH terms: Mycoses; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous; Lymphoma, Non-Hodgkin
Intervention: anti-thymocyte globulin; cyclosporine; Lymphoid radiation
Intervention description: ATG will be administered five times intravenously at 1.5 mg/kg/day from day -11 through day -7 for a total dose of 7.5 mg/kg; 5 mg/kg PO or IV; TLI is administered ten times in 80c- 120c Gy fractions on day -11 through day -7 and day -4 through day -1
Intervention MeSH terms: Cyclosporine; Cyclosporins; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Non-myeloablative approach for allogeneic transplant is a reasonable option, especially given
      that the median age at diagnosis is 55-60 years and frequently present compromised skin in
      these patients, which increases the risk of infection. Therefore, we propose a clinical study
      with allogeneic hematopoietic stem cell transplantation (HSCT) using a unique
      non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary
      syndrome (MF/SS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1 standard
             systemic therapy or are not candidates for standard therapy.

          2. Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.

          3. Age > 18 years and <= 75 years.

          4. Karnofsky Performance Status >= 70%.

          5. Corrected DLCO >= 40%

          6. Left ventricle ejection fraction (LVEF) > 30%.

          7. ALT and AST must be <= 3X normal. Total bilirubin <= 3 mg/dL unless hemolysis or
             Gilbert's disease.

          8. Estimated creatinine clearance >= 50 ml/min.

          9. Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in
             HLA-A, B, C or DRB1.

         10. Signed informed consent.

         11. Patients with prior malignancies diagnosed > 5 years ago without evidence of disease
             are eligible.

         12. Patients with a prior malignancy treated < 5 years ago but have a life expectancy of >
             5 years for that malignancy are eligible.

        Donor Inclusion Criteria

          1. Age >=17.

          2. HIV seronegative.

          3. No contraindication to the administration of G-CSF.

          4. Willing to have a central venous catheter placed for apheresis if peripheral veins are
             inadequate

        Exclusion Criteria:

          1. Uncontrolled active infection.

          2. Uncontrolled congestive heart failure or angina.

          3. Pregnancy or nursing patients will be excluded from the study.

          4. Those who are HIV-positive will be excluded from the study due to high risk of lethal
             infection after hematopoietic cell transplantation.

        Donor Exclusion Criteria

          1. Serious medical or psychological illness.

          2. Pregnant or lactating women are not eligible

          3. Prior malignancies within the last 5 years except for non-melanoma skin cancers