Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer, Cancer, Infectious Disease, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/13/2019 |
| Start Date: | May 2009 |
| End Date: | December 2022 |
| Contact: | Michelle Chin |
| Email: | mchin88@stanford.edu |
| Phone: | 650-721-4183 |
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
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.
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.
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 GVHD and time to engraftment.
-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 GVHD and time to engraftment.
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
We found this trial at
1
site
291 Campus Dr
Stanford, California 94305
Stanford, California 94305
(650) 725-3900
Principal Investigator: Wen-Kai Weng
Phone: 650-721-4183
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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