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Sponsored by: |
Stanford University |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00481832 |
The purpose of this trial is to develop an alternative treatment for patients with poor risk non-Hodgkin's lymphoma. This trial uses a combination of high dose chemotherapy with stem cell transplant using the patient's own cells. This is followed with non-myeloablative transplant using stem cells from a related or unrelated donor to try and generate an anti-lymphoma response from the new immune system.
Condition | Intervention | Phase |
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Lymphoma, Non-Hodgkin |
Procedure: Autologous transplantation Procedure: Allogeneic transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Autologous Followed by Non-Myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 25 |
Study Start Date: | January 2007 |
Currently, patients with recurrent or primary refractory non-Hodgkin's lymphoma are treated with second-line chemotherapy (usually 2-3 courses) for the purpose of cytoreduction and to establish sensitivity to chemotherapy. Thereafter, peripheral blood progenitor cells are mobilized with cyclophosphamide and granulocyte colony stimulating factor, apheresed and cryopreserved. The standard high dose regimen consists of augmented carmustine, etoposide and cyclophosphamide. Unfortunately, there are subgroups of patients with poor outcomes using autologous transplantation including those with transformed lymphoma as well as patients who do not attain a minimal disease state due to chemoresistant disease.
Past studies conducted at Stanford have included a group of 17 patients with transformed lymphoma who received autologous transplants, the median EFS and OS were 1.48 and 2.7 years respectively with a 7-year survival of only 20%. In comparison, patients with chemosensitive follicular lymphoma who received the same regimen also had a poor median EFS of 1.3 years, but the median survival was 6.7 years. The outcomes for patients with chemotherapy-resistant relapsed NHL is also poor with EFS in the range of 20% in many studies of autologous transplantation.
These groups of patients have limited disease control and survival with standard chemotherapy regimens, and although they often have excellent cytoreduction with the high-dose chemotherapy regimen, relapse remains the primary cause of treatment failure. The current trial utilizes a similar approach that has been taken with patients with multiple myeloma, who appear to benefit from an allogeneic graft-versus-tumor effect, using a combined autologous and non-myeloablative allogeneic transplant regimen to reduce transplant-related complications. Eligible patients will be treated with high-dose chemotherapy using BCNU, etoposide and cyclophosphamide with autologous hematopoietic cell support as a method of cytoreduction. Approximately 60-120 days after the autologous transplant, patients will receive an allogeneic transplant using a preparative regimen of total lymphoid irradiation and anti-thymocyte globulin in an attempt to develop a graft-versus-lymphoma effect.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:- Age 18 to 70 years.
Relapse after achieving initial remission or failure to achieve initial remission. Patients with residual radiographic abnormalities after primary therapy are eligible if abnormalities are FDG-PET positive. Eligible patients must have 1) transformed lymphoma, 2) mycosis fungoides that is resistant or refractory to therapy, 3) other histological subtypes in patients that do not have adequate cytoreduction to salvage chemotherapy to reach a minimal disease state, 4) patients in 2nd or greater relapse or 3 or subsequent remission, or 5) other patients with non-Hodgkin's lymphoma felt to have less than a 20% chance of event-free survival with autologous transplant after discussion with the BMT Faculty and the Principal Investigator
Patients must have a pretreatment serum bilirubin < 2 x the institutional ULN, a serum creatinine < 2 x the institutional ULN and measured or estimated creatinine clearance > 60 cc/min by the following formula (all tests must be performed within 28 days prior to registration):
Donor Selection/Evaluation:
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: BMT Referrals 650-723-0822 cctoffice@stanford.edu | |
Contact: Cancer Clinical Trials Office (650) 498-7061 | |
Sub-Investigator: Sandra Jeane Horning | |
Sub-Investigator: Laura Johnston | |
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 | |
Sub-Investigator: Youn H Kim | |
Sub-Investigator: Sally Arai | |
Sub-Investigator: Karl G. Blume | |
Sub-Investigator: Richard T. Hoppe |
Principal Investigator: | Wen-Kai Weng | Stanford University |
Study ID Numbers: | BMT185, 97623, BMT185, NCT00481832 |
Study First Received: | May 31, 2007 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00481832 |
Health Authority: | United States: Institutional Review Board |
Lymphatic Diseases Immunoproliferative Disorders Lymphoma, small cleaved-cell, diffuse |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |