A Phase I/II Study of Double Unit Umbilical Cord Blood (UCB) Transplantation Utilizing Graft Administration Via Intra-Bone Marrow Injection (Companion Protocol to MT2000-25)
- Determine the safety, in terms of infusional toxicity, of myeloablative unrelated donor
double-unit umbilical cord blood (UCB) transplantation via intra-bone marrow injection
(IBMI) in patients with advanced or high-risk hematologic malignancy.
- Determine whether treatment with this regimen improves the time to neutrophil
engraftment (compared to historical controls) in these patients.
- Determine the incidence of sustained donor engraftment in patients treated with this
- Determine the relative contribution of each UCB unit to initial and sustained donor
engraftment in these patients.
- Determine the incidence of grade II-IV and grade III-IV acute graft-vs-host disease
(GVHD) and chronic GVHD in patients treated with this regimen.
- Determine the incidence of day 100 and 180 transplant-related mortality in patients
treated with this regimen.
- Determine the probability of survival at 100 days and 1 year post-transplantation in
Outline: This is a nonrandomized study.
Patients receive a myeloablative conditioning regimen. Patients also receive
immunosuppression, growth factor, and supportive care as in protocol MT2005-10
Patients receive 2 units of donor umbilical cord blood (UCB) by intra-bone marrow injection
(IBMI) over 10 minutes each on day 0. If the IBMI procedure is not possible, then the UCB
units are given intravenously (IV.)
After completion of study therapy, patients are followed periodically for 5 years.
Projected Accrual: A total of 36 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median Number of Days to Neutrophil Engraftment
Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.
Daily through Day 60 post transplant
John E. Wagner, MD
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board