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.
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, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally every 8 hours on days -3 to 45. After completion of study treatment, patients are followed periodically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Undergo transplantation
Correlative studies
Correlative studies
Correlative studies
Given orally
Given IV
Given IV
Given IV
Given IV
Given orally or IV
Correlative studies
Undergo transplantation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Overall Survival
Number of participants alive at 180 days post engraftment.
Time frame: On day +180
Hematologic Engraftment
Number of participants that were able to complete engraftment by day 42.
Time frame: On day +42
Overall Survival
Number of participants that were alive.
Time frame: At 1 year
Overall Survival
Number of participants that were alive.
Time frame: At 2 years
Disease Free
Number of participants that were disease free
Time frame: At 1 year
Disease Free
Number of participants that were disease free
Time frame: At 2 years
Recurrence or Relapse
Number of subjects that had disease recurrence
Time frame: one year in patients post UCBT
Recurrence or Relapse
Number of subjects that had disease recurrence
Time frame: two years post transplant
Transplant Related Mortality
Number of subjects that died because of transplant
Time frame: On day 100 post transplant
Transplant Related Mortality
Number of subjects that died because of transplant
Time frame: On day 180 post transplant
Occurrence of Serious Infections
Number of participants that had infections
Time frame: 1 year
Immune Reconstitution
Immunodificency panel to see recovery of immune system. Number of participants that recovered.
Time frame: Periodically for 2 years
Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0
Number of participants that experienced toxicity related to the transplant
Time frame: by day +42
Incidence of Acute Graft-versus-host Disease (GVHD)
Number of participants that had acute GVHD
Time frame: At 100 days
Incidence of Chronic GVHD
Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR)
Time frame: At 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.