Clinical Trials

Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma

USA
California
Stanford

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.