A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Children and Adults With Hematologic Malignancies
OBJECTIVES: I. Determine the rates of hematologic and immune reconstitution in pediatric
patients with high risk hematologic malignancies in first remission or in second or
subsequent remission, and adult patients with acute lymphocytic leukemia (ALL) or acute
nonlymphocytic leukemia (ANLL) in second or subsequent remission, who are undergoing high
dose chemoradiotherapy followed by unrelated umbilical cord blood (UCB) transplantation. II.
Determine the incidence of graft-versus-host disease in this setting. III. Determine whether
contamination of umbilical cord blood with maternal cells is a clinical problem in this
setting. IV. Describe the incidence of leukemic relapse in these patients after UCB
transplantation. V. Describe the incidence of serious infections and secondary
lymphoproliferative diseases following transplantation with UCB in these patients. VI.
Determine specifically whether larger recipients (greater than 40 kg) can be durably
engrafted with unrelated UCB, and determine whether nucleated cell or progenitor cell
content of the graft is predictive of hematological engraftment.
OUTLINE: Patients undergo a back-up bone marrow harvest prior to treatment. Patients receive
9 fractions of total body irradiation (TBI) on days -9 to -5, followed by melphalan IV on
days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV on days -3 to -1. If
TBI is not allowed, busulfan is substituted and administered orally every 6 hours for 4 days
on days -8 to -5. On day 0, patients receive umbilical cord blood infusion. Cyclosporine and
methylprednisolone begin on day -2 and continue for 6 months. Patients are followed
indefinitely for survival and late toxicity.
PROJECTED ACCRUAL: A minimum of 48 patients will be accrued into this study within 4 years.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Barbara Jean Bambach, MD
Study Chair
Roswell Park Cancer Institute
United States: Food and Drug Administration
CDR0000066754
NCT00003661
June 1998
March 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
North Shore University Hospital | Manhasset, New York 11030 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Nemours Children's Clinic | Jacksonville, Florida 32207 |
Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
University of South Carolina School of Medicine | Columbia, South Carolina 29203 |
Division of Pediatric Surgery | Jacksonville, Florida 32207 |
New York Blood Center | New York, New York 10021 |