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RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant 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 healthy stem cells from a donor 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 tacrolimus and mycophenolate mofetil before and after transplant may stop this from happening.
PURPOSE: To look at the ability of umbilical cord blood cells from one or two unrelated donors to serve as a source of stem cells for people needing a bone marrow transplant.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE:
Conditioning: Patients receive myeloablative or reduced-intensity conditioning regimen according to age and prior treatment.
Umbilical cord blood transplantation (UCBT): All patients undergo single- or double-unit umbilical cord blood transplantation (UCBT)on day 0.
Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV continuously or orally twice daily on days -2 to 180 followed by a tapering and mycophenolate mofetil IV or orally twice daily on days 0-100 followed by a tapering over the next 3 months. Patients also receive filgrastim (G-CSF) IV or subcutaneously beginning on day 0* and continuing until blood counts recover.
NOTE: *In adult patients receiving a reduced intensity transplant, G-CSF will be started when the total white cell count falls below 2.5 x 109/L.
After completion of study treatment, patients are followed monthly for 1 year and then every 2-4 months thereafter.
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Inclusion and exclusion criteria
Patient and UCB Unit Selection:
Inclusion Criteria: General (Adults and Pediatrics)
Only one of the following should be present:
Inclusion Criteria (Adults - 18 years or older)
Inclusion Criteria (Pediatrics - 18 years and younger)
Inclusion Criteria - Donor Issues
Inclusion Criteria: Umbilical Cord Blood Unit-HLA Typing
Inclusion Criteria: Umbilical Cord Blood Unit-Cell dose
The total cell dose UCB1 + UCB2 will be ≥ 2.5 X 107 NC/kg of recipient body weight.
-Adult patients eligible for a double UCB SCT but without an appropriate second UCB unit will be enrolled in the study if their single UCB unit contains ≥ 2.5 x 107 NC/kg recipient body weight.
Exclusion Criteria
Primary purpose
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Interventional model
Masking
6 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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