Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
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ClinicalTrials.gov Identifier: NCT00896493 |
Recruitment Status
:
Recruiting
First Posted
: May 11, 2009
Last Update Posted
: October 20, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mycoses Sezary Syndrome Lymphoma, T-Cell, Cutaneous Bone Marrow Transplant Failure Lymphoma, Non-Hodgkin Cutaneous T-cell Lymphoma | Drug: anti-thymocyte globulin Drug: cyclosporine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | May 2009 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Total lymphoid irradiation & anti-thymocyte immunoglobulin |
Drug: anti-thymocyte globulin
1.5 mg/kg x 5 days, IV
Other Name: ATG
Drug: cyclosporine
5 mg/kg PO or IV
Other Names:
|
- To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival. [ Time Frame: 2 years ]
- To evaluate the incidence and extent of acute and chronic GVHD and time to engraftment. [ Time Frame: acute-first 100 days after transplant chronic-from 100days year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896493
Contact: Physician Referrals | (650) 723-0822 |
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Physician Referrals 650-723-0822 | |
Principal Investigator: Wen-Kai Weng | |
Sub-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: Robert Lowsky | |
Sub-Investigator: David Miklos | |
Sub-Investigator: Robert S Negrin | |
Sub-Investigator: Judith Anne Shizuru |
Principal Investigator: | Wen-Kai Weng | Stanford University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00896493 History of Changes |
Other Study ID Numbers: |
BMT206 SU-04062009-2138 ( Other Identifier: Stanford University ) 16213 ( Other Identifier: Stanford IRB ) |
First Posted: | May 11, 2009 Key Record Dates |
Last Update Posted: | October 20, 2016 |
Last Verified: | October 2016 |
Additional relevant MeSH terms:
Lymphoma Lymphoma, T-Cell Mycoses Sezary Syndrome Lymphoma, T-Cell, Cutaneous Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclosporins |
Cyclosporine Antilymphocyte Serum Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors |