Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
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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 HSCT using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced MF/SS.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2022 |
| Estimated Primary Completion Date: | December 2022 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: BMT Referrals | (650) 723-0822 |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: BMT Referrals 650-723-0822 | |
| Contact: Cancer Clinical Trials Office (650) 498-7061 | |
| 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: Ginna Laport | |
| 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 |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00896493 History of Changes |
| Other Study ID Numbers: | BMT206, SU-04062009-2138, 16213 |
| Study First Received: | May 7, 2009 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Mycoses Sezary Syndrome Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antilymphocyte Serum |
Cyclosporins Cyclosporine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013