Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Nonmalignant Hematologic Disease
- Conditions
- LymphomaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative DiseasesLeukemia
- Registration Number
- NCT00003913
- Lead Sponsor
- Fred Hutchinson Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood transplantation plus combination chemotherapy in treating patients who have hematologic cancer or nonmalignant hematologic disease.
- Detailed Description
OBJECTIVES:
* Determine the efficacy of umbilical cord blood transplantation, as measured by durable neutrophil engraftment, in patients with malignant or nonmalignant hematological disease.
* Determine the disease-free survival and long-term survival in patients treated with this regimen.
* Determine the incidence of neutrophil engraftment, primary and secondary graft failure, platelet engraftment, and RBC engraftment in patients treated with this regimen.
* Determine the incidence and severity of acute and chronic graft-versus-host disease, complications (infection, veno-occlusive disease, interstitial pneumonitis), relapse, other malignancies, lymphoproliferative disorders, and posttransplantation myelodysplasia in patients treated with this regimen.
* Determine the immune reconstitution in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to disease group (malignant vs nonmalignant). Patients with malignant disease are further stratified according to quality of HLA match (1 or 2/6 vs 3/6 vs 4/6 vs 5/6 or 6/6), cell dose, and age.
Patients are assigned to one of three conditioning regimens, depending on disease.
* Group A (malignant disease ): Patients undergo total body irradiation (TBI) once on day -8 and twice daily on days -7 to -4. Male patients with acute lymphocytic leukemia (ALL) undergo radiotherapy boost to testes. Patients receive cyclophosphamide (CTX) IV on days -3 and -2 and methylprednisolone (MePRDL) IV and anti-thymocyte globulin (ATG) IV on days -3 to -1.
* Group B (inborn errors of metabolism/storage disease): Patients receive oral busulfan (BU) every 6 hours on days -6 and -5, CTX IV on days -4 and -3, and MePRDL IV and ATG IV every 12 hours on days -2 and -1.
* Group C (other nonmalignant diseases): Patients receive oral BU every 6 hours on days -9 to -6, CTX IV on days -5 to -2, and MePRDL IV and ATG IV on days -3 to -1.
Patients in all groups receive cord blood IV over a maximum of 30 minutes on day 0. Patients also receive MePRDL IV with the first half of the infusion administered immediately before the cord blood infusion and filgrastim (G-CSF) IV beginning 4 hours after transplantation and continuing until blood counts recover.
Patients are followed at 30, 60, and 90 days; at 6 months; and then annually thereafter.
PROJECTED ACCRUAL: Approximately 390 patients will be accrued for this study within 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 390
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States
Warren Grant Magnuson Clinical Center
🇺🇸Bethesda, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Spectrum Health and DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States