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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00882895 |
This is a research study testing a new approach to treating high-risk non-Hodgkin's lymphoma consisting of an autologous hematopoietic (blood) stem cell transplant (using a patient's own hematopoietic cells) followed by a non-myeloablative allogeneic transplantation (transplant from another individual).
The investigators hypothesize that the addition of the second non-myeloablative transplant will improve the chances for long-term control of lymphoma.
Condition | Intervention | Phase |
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Lymphoma, Non-Hodgkin |
Procedure: Autologous Transplant Procedure: Allogeneic Transplant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, 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: | June 2009 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
One Arm: Autotransplant followed by Allogeneic Transplant
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Procedure: Autologous Transplant
BEAM Conditioning:
Autologous Transplant
Minimum of 2 months following autologous transplant TLI/ATG Conditioning:
Stem Cell Infusion Day 0 Immunosuppression:
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The approach to recurrent or primary refractory non-Hodgkin's lymphoma has been to treat patients with second-line chemotherapy (usually 2-3 courses) for the purposes of cytoreduction and to establish sensitivity to chemotherapy. Thereafter, peripheral blood progenitor cells have been mobilized with cyclophosphamide and granulocyte colony stimulating factor, apheresed and cryopreserved. 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.
In a group of 17 patients with transformed lymphoma who received autologous transplants at Stanford University, 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 we have 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. In addition, there are limited reports of using an autologous/allogeneic approach for lymphoma patients using non-myeloablative allogeneic transplants. Eligible patients will be treated with high-dose chemotherapy using BCNU, etoposide, cytarabine and melphalan 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
Eligible patients must have either
If the ejection fraction is 40-50%, patients must have an exercise echocardiogram or dobutamine-echo with a normal response to exercise.
Exclusion Criteria
Contact: Keith Stockerl-Goldstein, MD | 314 747-8439 | ksgoldstein@wustl.edu |
Contact: Nick Fisher | 314-454-5102 | nfisher@wustl.edu |
United States, Missouri | |
Washington University | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Keith Stockerl-Goldstein, MD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Keith Stockerl-Goldstein, MD ) |
Study ID Numbers: | 09-0042 |
Study First Received: | April 15, 2009 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00882895 History of Changes |
Health Authority: | United States: Institutional Review Board |
Lymphoma, Non-Hodgkin Transplantation, Autologous Transplantation, Homologous Total Lymphoid Irradiation Anti-thymocyte globulin |
Melphalan Immunoproliferative Disorders Immunologic Factors Methylprednisolone Carmustine Methylprednisolone acetate Prednisolone acetate Tacrolimus Immunosuppressive Agents Etoposide phosphate Antilymphocyte Serum |
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Prednisolone Mycophenolate mofetil Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Etoposide Cytarabine Methylprednisolone Hemisuccinate |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Antilymphocyte Serum Lymphatic Diseases Neoplasms Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |