At a glance
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A Multi-Center, Phase II Trial of Non-Myeloablative Conditioning (NST) and Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies (BMT CTN #0604)
In Brief
A Phase 2 clinical trial evaluating Hematopoietic Umbilical Cord Blood Stem Cell Transplantation and GVHD prophylaxis for Precursor B-Cell Lymphoblastic Leukemia-Lymphoma and 5 related conditions. Completed, enrolled 54 participants across 16 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.