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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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
5 mg/kg PO or IV
TLI is administered ten times in 80c- 120c Gy fractions on day -11 through day -7 and day -4 through day -1
Stanford University School of Medicine
Stanford, California, United States
Progression-Free Survival (PFS) at 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
Time frame: 180 days
Number of Participants With Acute Graft-versus-host Disease (GVHD)
Cumulative incidence at 6 months. GvHD was assessed using the 2015 NIH consensus criteria.
Time frame: 6 months
Number of Participants With Chronic Graft-versus-host Disease (GVHD)
Cumulative incidence at 6 months (any grade). GvHD was assessed using the 2015 NIH consensus criteria.
Time frame: 2 years
Overall Survival (OS)
Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause (Kaplan-Meier estimate).
Time frame: 2 years
Overall Survival (OS)
Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause (Kaplan-Meier estimate).
Time frame: 5 years
Mortality
Total count of non-relapsed mortality and mortality from relapsed disease.
Time frame: Up to 5 years
Treatment Related Mortality
Time frame: Up to 5 years
Event Free Survival (EFS)
Event-free survival (EFS) is the time measurement between the day of allogeneic transplant and the first documented recurrence or death from any cause (Kaplan-Meier estimate).
Time frame: 2 years
Event Free Survival (EFS)
Event-free survival (EFS) is the time measurement between the day of allogeneic transplant and the first documented recurrence or death from any cause (Kaplan-Meier estimate).
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.