Stanford University School of Medicine
Stanford, California, 94305, United States
NCT Number: NCT00896493
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).
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Stanford, California, 94305, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Donor Inclusion Criteria
Exclusion criteria
Donor Exclusion Criteria
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: ATG
5 mg/kg PO or IV
Other names: cyclosporin, cyclosporin A
TLI is administered ten times in 80c- 120c Gy fractions on day -11 through day -7 and day -4 through day -1
Other names: Total lymphoid irradiation (TLI)
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
Time frame: 6 months
Cumulative incidence at 6 months. GvHD was assessed using the 2015 NIH consensus criteria.
Time frame: 2 years
Cumulative incidence at 6 months (any grade). GvHD was assessed using the 2015 NIH consensus criteria.
Time frame: 2 years
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
Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause (Kaplan-Meier estimate).
Time frame: Up to 5 years
Total count of non-relapsed mortality and mortality from relapsed disease.
Time frame: Up to 5 years
Time frame: 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 (Kaplan-Meier estimate).
Time frame: 5 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 (Kaplan-Meier estimate).
Stanford University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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