Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
Study Details
Study Description
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, 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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 of acute and chronic GVHD and time to engraftment.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Total lymphoid irradiation & anti-thymocyte immunoglobulin TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg. |
Drug: anti-thymocyte globulin
ATG will be administered five times intravenously at 1.5 mg/kg/day from day -11 through day -7 for a total dose of 7.5 mg/kg
Other Names:
Drug: cyclosporine
5 mg/kg PO or IV
Other Names:
Radiation: Lymphoid radiation
TLI is administered ten times in 80c- 120c Gy fractions on day -11 through day -7 and day -4 through day -1
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival (PFS) at 180 days [180 days]
Progression-Free Survival (PFS) will be assessed at 180 days
Secondary Outcome Measures
- To evaluate the incidence and extent of acute and chronic GVHD and time to engraftment. [acute-first 100 days after transplant chronic-from 100days year]
- Overall Survival (OS) [2 years]
Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause.
- Treatment related mortality [2 years]
Total count of treatment related mortality will be reported.
- Event Free survival (EFS) [2 years]
Event-free survival (EFS) is the time measurement between the day of allogeneic transplant and the first documented recurrence or death from any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
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Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1 standard systemic therapy or are not candidates for standard therapy.
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Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
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Age > 18 years and <= 75 years.
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Karnofsky Performance Status >= 70%.
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Corrected DLCO >= 40%
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Left ventricle ejection fraction (LVEF) > 30%.
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ALT and AST must be <= 3X normal. Total bilirubin <= 3 mg/dL unless hemolysis or Gilbert's disease.
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Estimated creatinine clearance >= 50 ml/min.
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Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1.
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Signed informed consent.
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Patients with prior malignancies diagnosed > 5 years ago without evidence of disease are eligible.
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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
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Age >=17.
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HIV seronegative.
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No contraindication to the administration of G-CSF.
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Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate
Exclusion Criteria:
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Uncontrolled active infection.
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Uncontrolled congestive heart failure or angina.
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Pregnancy or nursing patients will be excluded from the study.
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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
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Serious medical or psychological illness.
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Pregnant or lactating women are not eligible
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Prior malignancies within the last 5 years except for non-melanoma skin cancers
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Stanford University School of Medicine | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
Investigators
- Principal Investigator: Wen-Kai Weng, Stanford University
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB-16213
- SU-04062009-2138
- 16213
- BMT206