Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer
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 the donor's umbilical cord blood are injected into the patient's bone marrow they may help make stem cells, red blood cells, white blood cells, and platelets.
Purpose: This phase I/II trial is studying the side effects of donor umbilical cord blood transplant when given directly into the bone marrow and to see how well it works in treating patients with hematologic cancer.
Procedure: umbilical cord blood transplantation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Median Number of Days to Neutrophil Engraftment [ Time Frame: Daily through Day 60 post transplant ] [ Designated as safety issue: Yes ]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.
- Number of Patients Achieving Neutrophil Recovery [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months.
- Number of Patients With Evidence of Engraftment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Number of patients who received both cord blood units and achieved sustained donor engraftment
- Number of Patients With Acute Graft-versus-host Disease (GVHD) [ Time Frame: 100 days post transplant ] [ Designated as safety issue: Yes ]Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant.
- Number of Patients With Transplant-related Mortality (TRM) [ Time Frame: Day 100 and Day 180 ] [ Designated as safety issue: Yes ]Number of patients who were deceased at days 100 and 180 from any cause other than relapse.
- Number of Patients Surviving at Day 100 and 1 Year. [ Time Frame: Day 100 and 1 year ] [ Designated as safety issue: Yes ]Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant.
- Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) [ Time Frame: 100 days post transplant ] [ Designated as safety issue: Yes ]Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant.
- Number of Patients With Chronic Graft-versus-host Disease (GVHD). [ Time Frame: 1 year post transplant ] [ Designated as safety issue: Yes ]Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.
|Study Start Date:||June 2005|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Experimental: Transplant Patients
Patients receiving umbilical cord blood transplantation.
Procedure: umbilical cord blood transplantation
The graft will be given by slow injection into each posterior iliac crest.
Other Name: UCBT
- 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 regimen.
- 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 these patients.
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 (NCT00309842).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295880
|Study Chair:||John E. Wagner, MD||Masonic Cancer Center, University of Minnesota|