NCT00295880

Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer

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)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Objectives: Primary * 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. Secondary * 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.

Conditions

• Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
PROCEDURE	umbilical cord blood transplantation	The graft will be given by slow injection into each posterior iliac crest.

Timeline

• Start date: 2005-06-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-02-24
• Last updated: 2017-12-28
• Results posted: 2009-09-03