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
Overview
- Phase
- Phase 2
- Intervention
- anti-thymocyte globulin
- Conditions
- Mycoses
- Sponsor
- Stanford University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival (PFS) at 180 Days
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 hematopoietic stem cell transplantation (HSCT) using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary syndrome (MF/SS).
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 graft-versus-host disease (GVHD) and time to engraftment.
Investigators
Wen-Kai Weng
Associate Professor of Medicine
Stanford University
Eligibility Criteria
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 DRB
- •Signed informed consent.
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.
- •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
Arms & Interventions
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.
Intervention: anti-thymocyte globulin
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.
Intervention: cyclosporine
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.
Intervention: Lymphoid radiation
Outcomes
Primary Outcomes
Progression-Free Survival (PFS) at 180 Days
Time Frame: 180 days
Progression-Free Survival (PFS; time to disease progression or death from any cause) assessed at 180 days (Kaplan-Meier estimate). Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Secondary Outcomes
- Treatment Related Mortality(Up to 5 years)
- Number of Participants With Acute Graft-versus-host Disease (GVHD)(6 months)
- Mortality(Up to 5 years)
- Event Free Survival (EFS)(5 years)
- Number of Participants With Chronic Graft-versus-host Disease (GVHD)(2 years)
- Overall Survival (OS)(5 years)