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

Trial ID or NCT#

NCT00896493

Status

not recruiting iconNOT RECRUITING

Purpose

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).

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  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.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. Donor Inclusion Criteria
  2. 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. 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.
    1. Donor Exclusion Criteria
  2. 1. Serious medical or psychological illness.2. Pregnant or lactating women are not eligible3. Prior malignancies within the last 5 years except for non-melanoma skin cancers
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Investigator(s)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Lymphoma specialist, Medical oncologist, Multiple myeloma specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Robert Lowsky
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Lynn Million
Lynn Million
Radiation oncologist
Clinical Professor, Radiation Oncology - Radiation Therapy
Sunil Arani Reddy
Sunil Arani Reddy
Medical oncologist, Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology
Laura Johnston
Laura Johnston
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist, Hematologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Robert Negrin
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Youn H Kim, MD
Youn H Kim, MD
Dermatologic oncologist, Cutaneous oncology specialist, Dermatologist
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)
Sally Arai
Sally Arai
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Richard Hoppe
Richard Hoppe
Radiation oncologist
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Judith Shizuru
Judith Shizuru
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist, Hematologist-Oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

Michelle Chin
650-721-4183

View on ClinicalTrials.gov