Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00882895|
Recruitment Status : Active, not recruiting
First Posted : April 17, 2009
Last Update Posted : January 11, 2019
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 or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin||Procedure: Stem cell infusion Procedure: TLI Drug: Anti-thymocyte globulin Drug: Solumedrol Drug: Tacrolimus Drug: Mycophenolate mofetil||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma|
|Actual Study Start Date :||May 5, 2009|
|Estimated Primary Completion Date :||June 1, 2028|
|Estimated Study Completion Date :||June 1, 2028|
Experimental: Allogeneic Transplant
Procedure: Stem cell infusion
Drug: Anti-thymocyte globulin
Drug: Mycophenolate mofetil
- Determine the event free survival [ Time Frame: Up to 10 years from transplant ]
- Determine the toxicities [ Time Frame: Day 100 ]
- To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism. [ Time Frame: Day 56, Day 100, Day 180, and Day 365 ]
- To evaluate the incidence and extent of acute and chronic GVHD. [ Time Frame: Up to 10 years ]
- To evaluate the overall and non-relapse mortality rate. [ Time Frame: Up to 10 years ]
- Incidence of chemotherapy-associated pneumonitis [ Time Frame: Day 100 ]
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): NCT00882895
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Keith Stockerl-Goldstein, MD||Washington University School of Medicine|