Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
NCT ID: NCT00896493
Last Updated: 2023-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2009-05-31
2022-12-31
Brief Summary
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Detailed Description
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-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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
cyclosporine
5 mg/kg PO or IV
Lymphoid radiation
TLI is administered ten times in 80c- 120c Gy fractions on day -11 through day -7 and day -4 through day -1
Interventions
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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
cyclosporine
5 mg/kg PO or IV
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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
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.
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
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Wen-Kai Weng
Associate Professor of Medicine
Principal Investigators
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Wen-Kai Weng
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Countries
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References
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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.
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.
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 in cutaneous T-cell lymphoma. Blood Adv. 2020 Sep 22;4(18):4474-4482. doi: 10.1182/bloodadvances.2020001627.
Weng WK, Armstrong R, Arai S, Desmarais C, Hoppe R, Kim YH. Minimal residual disease monitoring with high-throughput sequencing of T cell receptors in cutaneous T cell lymphoma. Sci Transl Med. 2013 Dec 4;5(214):214ra171. doi: 10.1126/scitranslmed.3007420.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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SU-04062009-2138
Identifier Type: OTHER
Identifier Source: secondary_id
16213
Identifier Type: OTHER
Identifier Source: secondary_id
BMT206
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-16213
Identifier Type: -
Identifier Source: org_study_id
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