PURPOSE:

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.

ELIGIBILITY:

Ages Eligible for Study:                     18 Years and older
Genders Eligible for Study:               Both
Conditions:

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.
 

INCLUSION CRITERIA:

• 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

• Signed informed consent.
   

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

EXCLUSION CRITERIA:

• 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

SPONSOR:

Stanford University

CLINICALTRIALS.GOV IDENTIFIER:

NCT00896493

CONTACT:

Stanford University School of Medicine
300 Pasteur Drive, Stanford, CA 94305
BMT Referrals, 650.723.0822
Principal Investigator: Youn H. Kim, M.D.