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Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
Not Recruiting
Trial ID: NCT00896493
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 hematopoietic stem cell transplantation (HSCT) using a unique
non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary
syndrome (MF/SS).
Official Title
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
Stanford Investigator(s)
Wen-Kai Weng, MD, PhD
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Robert Lowsky
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Lynn Million
Clinical Professor, Radiation Oncology - Radiation Therapy
Sunil Arani Reddy
Clinical Associate Professor, Medicine - Oncology
Laura Johnston
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Youn H Kim, MD
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)
Sally Arai
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Richard Hoppe
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Judith Shizuru
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)
Eligibility
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
Intervention(s):
drug: anti-thymocyte globulin
drug: cyclosporine
radiation: Lymphoid radiation
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Chin
650-721-4183