Clinical Trial: Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

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

Official Title: Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies

Brief Summary:

RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell transplant works in treating patients with hematologic malignancies.


Detailed Summary:

PRIMARY OBJECTIVES:

1. To establish the day +180 overall survival after a myeloablative unrelated double unit UCBT in a single institution setting.

SECONDARY OBJECTIVES:

  1. To determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies, who are undergoing myeloablative chemotherapy followed by infusion of double unit UCBT.
  2. To determine the contribution of each umbilical cord unit to immune reconstitution with a focus on both initial (day +21 BM, and +28 PB) and sustained engraftment (day +100 BM; PB at +14, +21, +28, +35, +42, +60, +100, +180, +1 and 2 years).
  3. To determine the probability of overall survival and disease free survival at one and two years.
  4. To describe the incidence of disease recurrence at one and two years in patients post UCBT.
  5. To describe the incidence of acute GVHD and chronic GVHD at 100 days and at one year, respectively.
  6. To determine the incidence of day 100 and 180 treatment related mortality.
  7. To determine the incidence of serious infectious complications in the first year after transplant.
  8. To determine the incidence of donor-derived neutrophil and platelet recovery.
  9. To determine the incidence of secondary lymphoproliferative diseases following transplantation with umbilical cord blood.

OUTLINE:

PREPARATIVE REGIMEN: Patients receive oral busulfan every 6 hours on days -8 to -5, cyclophospha
Sponsor: Case Comprehensive Cancer Center

Current Primary Outcome: Overall survival [ Time Frame: On day +180 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hematologic engraftment [ Time Frame: On day +42 ]
  • Disease-free and overall survival [ Time Frame: At 1 and 2 years ]
  • Duration of response [ Time Frame: one and two years ]
  • Transplant related mortality [ Time Frame: On day 100 and 180 ]
  • Recurrence or relapse [ Time Frame: one and two years in patients post UCBT ]
  • Occurrence of serious infections [ Time Frame: 1 year ]
  • Immune reconstitution [ Time Frame: Periodically for 2 years ]
  • Toxicity related to UCB transplantation and cytoreduction as assessed by CTC v3.0 [ Time Frame: three consecutive measurements on different days by day +42 ]
  • Incidence of acute graft-versus-host disease (GVHD) [ Time Frame: At 100 days ]
  • Incidence of chronic GVHD [ Time Frame: At 1 year ]


Original Secondary Outcome: Same as current

Information By: Case Comprehensive Cancer Center

Dates:
Date Received: March 24, 2010
Date Started: March 2009
Date Completion:
Last Updated: December 18, 2015
Last Verified: December 2015