Pediatric Clinical Trials
Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ 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 hematopoietic stem cell transplantation (HSCT) using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary syndrome (MF/SS).
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: anti-thymocyte globulin
- drug: cyclosporine
- radiation: Lymphoid radiation
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Chin
650-721-4183
Not Recruiting