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)
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 2 years from the time of transplant
Measured at Year 2
No
Mary Horowitz, MD, MS
Study Director
Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
United States: Federal Government
657
NCT00912223
April 2009
November 2016
Name | Location |
---|---|
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
University of Minnesota | Minneapolis, Minnesota 55455 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
University of California, Davis Medical Center | Sacramento, California |
Stanford Hospital and Clinics | Stanford, California 94305 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
University Hospitals of Cleveland/Case Western | Cleveland, Ohio 44106 |
Ohio State/Arthur G. James Cancer Hospital | Columbus, Ohio 43210 |
University of Oklahoma Medical Center | Oklahoma City, Oklahoma 73104 |
West Virginia University | Morgantown, West Virginia 26506 |
University of North Carolina Hospital at Chapel Hill | Chapel Hill, North Carolina 27599 |
University of Florida College of Medicine | Gainesville, Florida 32610 |
University of California, San Diego (UCSD) Medical Center | La Jolla, California 92093 |
Dana-Farber Cancer Institute (DFCI)/Brigham & Women's Hospital | Boston, Massachusetts 02114 |
Dana-Farber Cancer Institute (DFCI)/Massachusetts General Hospital | Boston, Massachusetts 02114 |
University of Texas, MD Anderson Cancer Research Center | Houston, Texas 77030 |