Blood Stem Cell Transplant With Low Dose Chemotherapy for Relapsed Follicular Non-Hodgkin's Lymphoma (BMT CTN 0701)
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|ClinicalTrials.gov Identifier: NCT00912223|
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : November 21, 2016
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin||Biological: Hematopoietic Stem Cell Transplant||Phase 2|
Follicular NHL, a type of blood cancer, is the second most common type of non-Hodgkin's lymphoma, with approximately 15,000 new cases being diagnosed each year in the United States. Chemotherapy is a common treatment option for people with NHL, and at first most people achieve cancer remission with initial chemotherapy. However, after the initial chemotherapy, people with this disease typically experience a continuous pattern of relapse that results in progressively shorter remission durations. A blood stem cell transplant is another treatment option for people with follicular NHL. In a blood stem cell transplant procedure, healthy blood stem cells are taken from a donor and transplanted into the patient. The cells can be donated by a family member or an unrelated donor who has a similar tissue type. Typically, people who are undergoing a blood stem cell transplant receive high doses of chemotherapy before the transplant to prepare their bodies to accept the donor stem cells. In this study, participants will undergo a type of stem cell transplant called a nonmyeloablative transplant, which involves a reduced intensity method of transplantation that does not require high doses of chemotherapy. The purpose of the study is to examine the effectiveness of a nonmyeloablative allogeneic blood stem cell transplant at improving survival rates in people with relapsed follicular NHL.
This study will enroll people with relapsed follicular NHL. At a baseline study visit, participants will undergo a medical history review, physical examination, blood collection, lung function testing, computed tomography (CT) scans, a bone marrow biopsy, and questionnaires to assess quality of life. Participants will be admitted to the hospital and on various days in the 2 weeks before the transplant, they will receive fludarabine, cyclophosphamide, rituximab, which are cancer medications, and tacrolimus, a medication that will help prevent graft-versus-host disease (GVHD), which is an attack by the donor cells on the body's normal tissues. Participants will then undergo the blood stem cell transplant. At various times during the 2 weeks after the transplant, participants will receive rituximab and methotrexate, which is another medication to prevent GVHD. They will also receive tacrolimus for at least 6 months to help prevent GVHD. Participants will remain in the hospital for as long as necessary to recover from the transplant. Follow-up study visits will occur weekly for Weeks 1 to 14, and then at Months 6, 12, 18, and 24. At each study visit, select baseline procedures will be repeated.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response (BMT CTN #0701)|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||August 2016|
Experimental: Hematopoietic Stem Cell Transplant
Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
Biological: Hematopoietic Stem Cell Transplant
NOTE: The - sign is the number of days before the transplant and the + sign is the number of days after the transplant.
The conditioning regimen will consist of the following:
Day 0 will be the day of the transplant.
The GVHD prophylaxis will consist of the following:
- Progression-Free Survival (PFS) [ Time Frame: Year 2 ]Patients are considered a failure for this endpoint if they die, or if they relapse/progress or receive anti-lymphoma therapy not including planned post-transplant radiation.
- Graft Failure [ Time Frame: Day 30 ]Primary graft failure is defined as a donor peripheral blood T cell chimerism < 5% at Day +30 post-transplant. Secondary Graft Failure is defined as documented engraftment followed by loss of graft as defined by donor peripheral blood T cell chimerism < 5%.
- Donor Cell Engraftment [ Time Frame: Days 30 and 100 ]Donor engraftment is defined as > 5% donor peripheral blood T cell chimerism by Day +30 post-transplant in the setting of Absolute Neutrophil Count (ANC) recovery (ANC >500/mm^3 for 3 consecutive days).
- Time to Neutrophil Recovery [ Time Frame: Day 60 ]Neutrophil Recovery is defined as ANC > 500/mm^3 for 3 consecutive days.
- Acute Graft-versus-Host Disease (GVHD) [ Time Frame: Day 100 ]The event is the incidence of grades II-IV acute GVHD from day of transplant, where grade IV is worst. The first day of acute GVHD onset at a certain grade will be used to calculate a cumulative incidence curve for that acute GVHD grade. GVHD should be monitored in accordance with BMT CTN manual of procedures guidelines. Acute GVHD grading was based on the consensus conference criteria (Przepiorka, et. al., 1994) and the Center for International Blood and Marrow Transplant Research (CIBMTR) grading criteria.
- Chronic GVHD [ Time Frame: Year 2 ]The event is the incidence and severity of chronic GVHD from day of transplant, a cumulative incidence curve will be computed along with a 95% confidence interval at two years post-transplant. Death prior to occurrence of chronic GVHD will be considered as a competing risk.
- Overall Survival [ Time Frame: Years 2 and 3 ]The event is death from any cause.
- Treatment-related Mortality (TRM) [ Time Frame: Year 3 ]The event is death occurring in patients in continuous complete remission. The TRM distribution will be estimated by the Kaplan-Meier curve.
- Infections [ Time Frame: Year 2 ]
- Quality of Life [ Time Frame: Year 2 ]
- Immunologic Reconstitution [ Time Frame: Year 1 ]Quantitative immunoglobulins (IgG)
- Incidence of Toxicities [ Time Frame: Year 2 ]Number of participants that experiences at least one grade 3 - 5 toxicity during the first two years, where grade 5 is worst. Toxicity grades are based on the NCI CTCAE Version 3.0.
- Serum Rituximab (RTX) Levels [ Time Frame: Baseline, Days 28 and 365 ]RTX concentration levels within participants
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): NCT00912223
|Study Director:||Mary Horowitz, MD, MS||Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin|