Status:
COMPLETED
Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
Lead Sponsor:
Stanford University
Conditions:
Mycoses
Sezary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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,...
Detailed Description
Primary Objectives -To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival. Secondary Objectives -To evaluate the incidence and extent...
Eligibility Criteria
Inclusion
- 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.
- Patients with prior malignancies diagnosed \> 5 years ago without evidence of disease are eligible.
- 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
- Age \>=17.
- HIV seronegative.
- No contraindication to the administration of G-CSF.
- Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00896493
Start Date
May 1 2009
End Date
December 1 2022
Last Update
May 11 2023
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305