Evaluating the Safety and Effectiveness of an Umbilical Cord Blood Stem Cell Transplant (BMT CTN 0604)
Condition: Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Burkitt Lymphoma; Lymphoma, B-Cell; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myeloid; Lymphoma, B-Cell; Leukemia, Myeloid, Acute; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      A bone marrow transplant, which is a type of stem cell transplant, is a treatment option for
      people with leukemia or lymphoma. Recently, stem cell transplants using umbilical cord blood
      have become a treatment option for people with these types of cancers. This study will
      evaluate the effectiveness of a stem cell transplant using umbilical cord blood, along with
      lower doses of chemotherapy, to treat people with leukemia or lymphoma.
    

Detailed description: 
      Leukemia and lymphoma are types of blood cancers. Chemotherapy is a common treatment option
      for people with these types of cancers, but if the cancer does not respond well to
      chemotherapy, or if the cancer returns, people may need to consider other options. A bone
      marrow transplant, which is a type of stem cell transplant in which healthy bone marrow is
      donated to a patient by a related or unrelated donor, is commonly used to treat leukemia and
      lymphoma. Recently, stem cell transplants using umbilical cord blood have become a viable
      option to treat these types of cancers. Traditionally, umbilical cord blood, which is the
      blood left over in the placenta after a baby is born, has been disposed of with the placenta.
      However, over the past few years, doctors have begun to collect and freeze the umbilical cord
      blood cells so that they may be used in stem cell transplant procedures at a later time.

      Typically, people who are undergoing a 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 new type of stem cell transplant called a
      nonmyeloablative transplant, which is a reduced intensity method of transplantation that does
      not require high doses of chemotherapy. The purpose of the study is to examine the safety and
      effectiveness of a nonmyeloablative stem cell transplant that uses umbilical cord blood as a
      treatment option for people with leukemia or lymphoma.

      This study will enroll people with leukemia or lymphoma. Participants will be admitted to the
      hospital and will first receive a type of chemotherapy called cyclophosphamide, which will be
      given intravenously on the sixth day before the transplant. In addition, another type of
      chemotherapy, fludarabine, will be given intravenously each day for 5 days before the
      transplant. Three days before the transplant, participants will receive cyclosporine and
      mycophenolate mofetil (MMF), to help prevent the body from rejecting the stem cells and to
      help decrease the risk of developing a complication called graft-versus-host-disease (GVHD),
      which is an attack by the donor cells on the body's normal tissues. Some participants may
      receive tacrolimus instead of cyclosporine. After 6 days, participants will receive a small
      dose of radiation. The next day, participants will undergo the umbilical cord blood stem cell
      transplant.

      Participants will remain in the hospital for approximately 2 to 3 months total, but possibly
      longer if there are complications. Beginning on the first day after the transplant,
      participants will receive daily injections of a growth factor called granulocyte-colony
      stimulating factor (G-CSF), which is a natural protein that increases the white blood cell
      count; G-CSF will be continued until a participant's white blood cell count is normal again.
      Participants will continue to receive MMF for 30 days and cyclosporine or tacrolimus for 180
      days after the transplant. While participants are in the hospital, blood samples will be
      collected regularly to evaluate the response and possible side effects to treatment,
      including GVHD. If necessary, participants will receive platelet and red blood cell
      transfusions. At follow-up study visits 6 months and 1 year after the transplant, blood
      samples will be obtained. Study researchers will keep track of participants' medical
      condition through phone calls or mailings to participants and their doctors once a year for
      the rest of the participants' lives.
    

Intervention name(s): Hematopoietic Umbilical Cord Blood Stem Cell Transplantation; GVHD prophylaxis
Intervention type(s): Biological; Biological
Intervention description(s): The transplant preparative regimen is listed below. The - sign is the number of days before the transplant.
Fludarabine: 40 mg/m^2 intravenously (IV) on Days -6, -5, -4, -3, and -2
Cyclophosphamide: 50 mg/kg IV on Day -6
Total body irradiation: 200 centigray (cGy) on Day -1; GVHD prophylaxis regimen will consist of:
Cyclosporine: beginning on Day -3 with the dose adjusted to maintain a level of 200-400 mg/mL
MMF: 1 gram IV three times a day (TID) if greater than 50 kg, or 15 mg/kg IV TID if less than 50 kg beginning on Day -3; continued until Day 30 or 7 days after engraftment, whichever day is later
Day 0 is the day of the infusion of the umbilical cord blood graft units, which will be obtained from partially HLA-matched unrelated donors.
Beginning on Day 1, participants will receive G-CSF 5 mcg/kg/day until absolute neutrophil count (ANC) is greater than or equal to 2,000/mm^3 for three consecutive measurements, each on different days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Lymphoblastic Leukemia/Lymphoma; Acute Myelogenous Leukemia; Mantel-Cell Lymphoma; Hematopoietic Transplant; Umbilical Cord Blood (UCB); Non-Myeloablative Transplant