Blood Stem Cell Transplant With Low Dose Chemotherapy for Relapsed Follicular Non-Hodgkin's Lymphoma (BMT CTN 0701)
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 2

Summary: 
      Blood stem cell transplants are one treatment option for people with lymphoma or other types
      of blood cancers. For this type of treatment, family members or unrelated donors with a
      similar tissue type usually donate their blood stem cells to the transplant patients. This
      study will evaluate the effectiveness of a type of blood stem cell transplant that uses lower
      doses of chemotherapy in people with relapsed follicular non-Hodgkin's lymphoma (NHL).
    

Detailed description: 
      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.
    

Intervention name(s): Hematopoietic Stem Cell Transplant
Intervention type(s): Biological
Intervention description(s): 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:
Rituxan 375 mg/m^2 on Day -13
Rituxan 1000 mg/m^2 on Days -6, +1, and +8
Fludarabine 30 mg/m^2 on Days -5 to -3
Cyclophosphamide 750 mg/m^2 on Days -5, -4, -3
Day 0 will be the day of the transplant.
The GVHD prophylaxis will consist of the following:
Tacrolimus .09 mg/kg/po (Day -2 thru Day +180). Doses will be adjusted to maintain blood levels of 5-15 ng/mL.
Methotrexate 5 mg/m^2 (Days +1, +3, and +6). Unrelated donor recipients will receive a fourth dose on Day +11.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Follicular Non-Hodgkin's Lymphoma; Hematopoietic Stem Cell Transplant (HSCT); Non-Myeloablative Transplant (NST)