Clinical Trial: Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center, Phase II Trial of Nonmyeloablative Conditioning (NST) and Transplantation of Partially HLA-Mismatched Bone Marrow From Related Donors for Patients With Hematologic Malignancies (BMT CT

Brief Summary: Bone marrow transplants are one treatment option for people with leukemia or lymphoma. Family members or unrelated donors with a similar type of bone marrow usually donate their bone marrow to the transplant patients. This study will evaluate the effectiveness of a new type of bone marrow transplant—one that uses lower doses of chemotherapy and bone marrow donated from family members with only partially matched bone marrow—in people with leukemia or lymphoma.

Detailed Summary:

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, a bone marrow transplant is another treatment option. In a bone marrow transplant procedure, healthy bone marrow is taken from a donor and transplanted into the patient. Bone marrow can be donated by a family member or an unrelated donor who has a similar type of bone marrow. Most bone marrow transplants are performed using a donor who is a perfect or close-to-perfect tissue match. However, for participants in this study, researchers have determined that a completely matched donor is unavailable within participants' families, and an unrelated donor match has not been found either. Participants do, however, have a family member who is a partial tissue match. Typically, people who are undergoing a bone marrow transplant receive high doses of chemotherapy before the transplant to prepare their bodies to accept the donor bone marrow. In this study, participants will undergo a new type of bone marrow 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 bone marrow transplant that uses partially matched bone marrow donated by a family member as a treatment option for people with leukemia or lymphoma.

This study will enroll people with leukemia or lymphoma who have a family member with a partial tissue match. Participants will be admitted to the hospital and will first receive a type of chemotherapy called fludarabine, which will be given intravenously for 5 days. In addition, another type of chemotherapy, cyclophosphamide, will be given intravenously on the first and second day.
Sponsor: Medical College of Wisconsin

Current Primary Outcome: Overall Survival at 180 Days From the Time of Transplant [ Time Frame: Measured at Month 6 and Year 1 ]

Original Primary Outcome: Overall Survival at 180 Days From the Time of Transplant [ Time Frame: Measured at 6 months and 1 year ]

Current Secondary Outcome:

  • Neutrophil Recovery [ Time Frame: Measured at Days 28, 56, 90, and 100 ]
    Cumulative incidence of neutrophil recovery >500/μL at day +56
  • Primary Graft Failure [ Time Frame: Measured at Day 67 ]
    Primary graft failure is defined as < 5% donor chimerism on all measurements.
  • Secondary Graft Failure [ Time Frame: Measured at Day 100 ]
    Secondary graft failure is defined as initial recovery followed by neutropenia with < 5% donor chimerism. If no chimerism assays were performed and absolute neutrophil count is < 500/mm3, then it will be counted as a secondary graft failure.
  • Platelet Recovery [ Time Frame: Measured at Days 56, 90, and 100 ]
    Platelet Recovery to 20K
  • Platelet Recovery [ Time Frame: Measured at Days 56, 90, and 100 ]
    Platelet Recovery to 50K
  • Donor Cell Engraftment [ Time Frame: Measured at Day 56 ]
    Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism ≥ 5% on Day ≥ 56 after transplantation. Chimerism should be evaluated on Days ~28, ~56, ~180, and ~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction.
  • Acute Graft-versus-host Disease (GVHD) [ Time Frame: Measured at Day 100 ]
  • Chronic GVHD [ Time Frame: Measured at Year 1 ]
  • Progression-free Survival [ Time Frame: Measured at Year 1 ]
    Progression-free survival is defined as the minimum time interval of the times to relapse/recurrence, to death or to last follow-up.
  • Treatment-related Mortality (TRM) [ Time Frame: Measured at 6 months and 1 year ]
  • Infections [ Time Frame: Measured at Year 1 ]
    Number of infections; infections will be reported by anatomic site, date of onset, organism and resolution, if any. Patients will be followed for infection for 1 year post-transplant.


Original Secondary Outcome:

  • Neutrophil Recovery [ Time Frame: Measured at Day 28 ]
  • Primary Graft Failure [ Time Frame: Measured at Day 56 ]
  • Secondary Graft Failure [ Time Frame: Measured at Day 100 ]
  • Platelet Recovery [ Time Frame: Measured at Days 100 and 180 ]
  • Donor cell engraftment [ Time Frame: Measured at Day 56 ]
  • Acute graft-versus-host disease [ Time Frame: Measured at Day 100 ]
  • Chronic graft-versus-host disease [ Time Frame: Measured at 1 year ]
  • Progression-free Survival [ Time Frame: Measured at 1 year ]
  • Treatment-related Mortality (TRM) [ Time Frame: Measured at Day 100 ]
  • Infections [ Time Frame: Measured at 1 year ]


Information By: Medical College of Wisconsin

Dates:
Date Received: February 20, 2009
Date Started: October 2008
Date Completion:
Last Updated: August 1, 2016
Last Verified: August 2016