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Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma

Information source: Stanford University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mycoses; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous; Bone Marrow Transplant Failure; Lymphoma, Non-Hodgkin; Cutaneous T-cell Lymphoma

Intervention: anti-thymocyte globulin (Drug); cyclosporine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Wen-Kai Weng, Principal Investigator, Affiliation: Stanford University

Overall contact:
Physician Referrals, Phone: (650) 723-0822

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 HSCT using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced MF/SS.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival.

Secondary outcome: To evaluate the incidence and extent of acute and chronic GVHD and time to engraftment.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 3. 1 Inclusion Criteria 3. 1.1 Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1 standard systemic therapy or are not candidates for standard therapy. 3. 1.2 Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. 3. 1.4 Age > 18 years and <= 75 years. 3. 1.5 Karnofsky Performance Status >= 70%. 3. 1.6 Corrected DLCO >= 40% 3. 1.7 Left ventricle ejection fraction (LVEF) > 30%. 3. 1.8 ALT and AST must be <= 3X normal. Total bilirubin <= 3 mg/dL unless hemolysis or Gilbert's disease. 3. 1.9 Estimated creatinine clearance >= 50 ml/min. 3. 1.10 Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1. 3. 1.11 Signed informed consent. 3. 3 Donor Inclusion Criteria 3. 3.1 Age >=17. 3. 3.2 HIV seronegative. 3. 3.3 Signed informed consent. 3. 3.4 No contraindication to the administration of G-CSF. 3. 3.5 Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate. 3. 5 Enrollment Enrollment occurs when all eligibility criteria are met. Exclusion Criteria: 3. 2 Exclusion Criteria 3. 2.1 Uncontrolled active infection. 3. 2.2 Uncontrolled congestive heart failure or angina. 3. 2.3 Pregnancy or nursing patients will be excluded from the study. 3. 2.4 Those who are HIV-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation. 3. 2.5 No prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five years. 3. 4 Donor Exclusion Criteria 3. 4.1 Serious medical or psychological illness. 3. 4.2 Pregnant or lactating women are not eligible 3. 4.3 Prior malignancies within the last 5 years except for non-melanoma skin cancers

Locations and Contacts

Physician Referrals, Phone: (650) 723-0822

Stanford University School of Medicine, Stanford, California 94305, United States; Recruiting
Physician Referrals, Phone: 650-723-0822
Wen-Kai Weng, Principal Investigator
Ranjana Hira Advani, Sub-Investigator
Sally Arai, Sub-Investigator
Jonathan Benjamin, Sub-Investigator
Richard T. Hoppe, Sub-Investigator
Laura A Johnson, Sub-Investigator
Youn H Kim, Sub-Investigator
Ginna Laport, Sub-Investigator
Robert Lowsky, Sub-Investigator
David Miklos, Sub-Investigator
Robert S Negrin, Sub-Investigator
Judith Anne Shizuru, Sub-Investigator
Additional Information

Starting date: May 2009
Last updated: February 12, 2014

Page last updated: August 20, 2015

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