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.
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Blood and Marrow Transplant; Skin Cancer; Lymphomas: Non-Hodgkin-Cutaneous Lymphoma; Sezary Syndrome; Mycoses
Health of Volunteers: People with the conditions listed in this trial can participate as controls.
- Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1 standard systemic therapy or are not candidates for standard therapy.
- Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center
- Age > 18 years and <= 75 years
- Karnofsky Performance Status >= 70%
- Corrected DLCO >= 40%
- Left ventricle ejection fraction (LVEF) > 30%
- ALT and AST must be <= 3X normal. Total bilirubin <= 3 mg/dL unless hemolysis or Gilbert’s disease
- Estimated creatinine clearance >= 50 ml/min
- Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1
DONOR INCLUSION CRITERIA:
- Age >=17
- HIV seronegative
- Signed informed consent
- No contraindication to the administration of G-CSF
- Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate
- Uncontrolled active infection
- Uncontrolled congestive heart failure or angina
- Pregnancy or nursing patients will be excluded from the study
- Those who are HIV-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation.
- No prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five years.
DONOR EXCLUSION CRITERIA:
- Serious medical or psychological illness.
- Pregnant or lactating women are not eligible
- Prior malignancies within the last 5 years except for non-melanoma skin cancers
Stanford University School of Medicine
300 Pasteur Drive, Stanford, CA 94305
BMT Referrals, 650.723.0822
Principal Investigator: Youn H. Kim, M.D.