A Phase II Study of Non-myeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) In Patients With Cutaneous T Cell Lymphoma

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 HSCT using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced MF/SS.

Stanford is now accepting new patients for this trial. Please contact Physician Referrals at 650-723-0822 for more information.

Investigator(s):

Intervention(s):

  • drug : cyclosporine
  • drug : anti-thymocyte globulin

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

3.1 Inclusion Criteria 3.1.1 Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1 standard systemic therapy or are not candidates for standard therapy. 3.1.2 Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. 3.1.4 Age > 18 years and <= 75 years. 3.1.5 Karnofsky Performance Status >= 70%. 3.1.6 Corrected DLCO >= 40% 3.1.7 Left ventricle ejection fraction (LVEF) > 30%. 3.1.8 ALT and AST must be <= 3X normal. Total bilirubin <= 3 mg/dL unless hemolysis or Gilbert's disease. 3.1.9 Estimated creatinine clearance >= 50 ml/min. 3.1.10 Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1. 3.1.11 Signed informed consent. 3.3 Donor Inclusion Criteria 3.3.1 Age >=17. 3.3.2 HIV seronegative. 3.3.3 Signed informed consent. 3.3.4 No contraindication to the administration of G-CSF. 3.3.5 Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate. 3.5 Enrollment Enrollment occurs when all eligibility criteria are met.

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Contact information

Primary Contact:

Physician Referrals 650-723-0822

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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