Lymphoma, Non-Hodgkin Clinical Trial
Official title:
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
Verified date | May 2023 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 38 |
Est. completion date | December 2022 |
Est. primary completion date | November 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1 standard systemic therapy or are not candidates for standard therapy. 2. Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. 3. Age > 18 years and <= 75 years. 4. Karnofsky Performance Status >= 70%. 5. Corrected DLCO >= 40% 6. Left ventricle ejection fraction (LVEF) > 30%. 7. ALT and AST must be <= 3X normal. Total bilirubin <= 3 mg/dL unless hemolysis or Gilbert's disease. 8. Estimated creatinine clearance >= 50 ml/min. 9. Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1. 10. Signed informed consent. 11. Patients with prior malignancies diagnosed > 5 years ago without evidence of disease are eligible. 12. 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 1. Age >=17. 2. HIV seronegative. 3. No contraindication to the administration of G-CSF. 4. Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate Exclusion Criteria: 1. Uncontrolled active infection. 2. Uncontrolled congestive heart failure or angina. 3. Pregnancy or nursing patients will be excluded from the study. 4. 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 1. Serious medical or psychological illness. 2. Pregnant or lactating women are not eligible 3. Prior malignancies within the last 5 years except for non-melanoma skin cancers |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18. — View Citation
Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995 Jun;15(6):825-8. — View Citation
Weng WK, Arai S, Rezvani A, Johnston L, Lowsky R, Miklos D, Shizuru J, Muffly L, Meyer E, Negrin RS, Wang E, Almazan T, Million L, Khodadoust M, Li S, Hoppe RT, Kim YH. Nonmyeloablative allogeneic transplantation achieves clinical and molecular remission — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 180 days | |
Secondary | Number of Participants With Acute Graft-versus-host Disease (GVHD) | Cumulative incidence at 6 months. GvHD was assessed using the 2015 NIH consensus criteria. | 6 months | |
Secondary | 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. | 2 years | |
Secondary | Overall Survival (OS) | Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause (Kaplan-Meier estimate). | 2 years | |
Secondary | Overall Survival (OS) | Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause (Kaplan-Meier estimate). | 5 years | |
Secondary | Mortality | Total count of non-relapsed mortality and mortality from relapsed disease. | Up to 5 years | |
Secondary | Treatment Related Mortality | Up to 5 years | ||
Secondary | 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). | 2 years | |
Secondary | 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). | 5 years |
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