Donor Umbilical Cord Blood Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
- Conditions
- LeukemiaLymphomaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative Diseases
- Registration Number
- NCT00055653
- Lead Sponsor
- Roswell Park Cancer Institute
- Brief Summary
RATIONALE: 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 allogeneic umbilical cord blood transplantation in treating patients who have leukemia, lymphoma, or nonmalignant hematologic disorders.
- Detailed Description
OBJECTIVES:
* Determine 180-day survival in patients with malignant or nonmalignant hematologic diseases treated with allogeneic umbilical cord blood transplantation. (Severe aplastic anemia, Fanconi anemia, and marrow failure syndromes strata are closed to accrual; adult \[over 18 years of age\] patient stratum is closed to accrual.)
* Determine disease-free and long-term survival in patients treated with this regimen.
* Determine the incidence of neutrophil engraftment, primary and secondary graft failure, platelet engraftment, and red blood cell engraftment in patients treated with this regimen.
* Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
* Determine the incidence of complications, including infection, veno-occlusive disease, and interstitial pneumonitis, in patients treated with this regimen.
* Determine the incidence of 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 grouped according to the following strata:
* Stratum I: Malignant disease, 5/6 or 6/6 HLA match, age 18 and under
* Stratum II: Malignant disease, 4/6 HLA match, age 18 and under
* Stratum III: Malignant disease, 3/6 HLA match, age 18 and under
* Stratum IV: Malignant disease, 2/6 or 1/6 HLA match, age 18 and under
* Stratum V (closed to accrual): Severe aplastic anemia, Fanconi anemia, or other marrow failure syndrome
* Stratum VI: Inborn errors of metabolism/storage diseases and other nonmalignant diseases not included in stratum V
* Stratum VII: Malignant disease receiving alternative conditioning regimen comprising busulfan and melphalan
* Stratum VIII (closed to accrual): Adult patients (over age 18)
* Conditioning therapy: Patients are assigned to 1 of 5 groups according to diagnosis.
* Group I (malignant disease or severe aplastic anemia \[severe aplastic anemia closed to accrual\]): Patients undergo total body irradiation (TBI) once or twice daily on days -8 to -4. Patients then receive cyclophosphamide IV on days -3 and -2, methylprednisolone IV on days -3 to 0, and antithymocyte globulin (ATG) IV once or twice daily on days -3 to -1.
* Group II (Fanconi anemia \[closed to accrual\]): Patients undergo TBI on day -6, and then receive cyclophosphamide IV and fludarabine IV on days -5 to -2, and methylprednisolone IV and ATG IV on days -5 to -1.
* Group III (inborn errors of metabolism/storage disease): Patients receive oral busulfan 4 times daily on days -9 to -6, cyclophosphamide as in group II, and methylprednisolone and ATG as in group I.
* Group IV (other nonmalignant diseases): Patients receive conditioning therapy as in group III. Patients with familial erythrophagocytic lymphohistiocytosis or Langerhans cell histiocytosis also receive etoposide on days -5 to -3.
* Group V (non-TBI regimen for leukemia patients under 2 years of age): Patients receive oral busulfan 4 times daily on days -8 to -5, melphalan IV on days -4 to -2, and methylprednisolone and ATG as in group I.
* Allogeneic umbilical cord blood transplantation: All patients undergo umbilical cord blood transplantation on day 0. Beginning on day 0 or 1, patients receive filgrastim (G-CSF) IV or subcutaneously daily until blood counts recover.
* Graft-versus-host disease prophylaxis: Patients receive cyclosporine (IV or oral) beginning between days -3 and -1 and continuing for 1 year after transplantation and methylprednisolone twice daily beginning on day 1 and continuing until blood counts recover.
Patients are followed weekly for 14 weeks, at 100 days, and at 4, 5, 6, 9, 12, 18, 24, and 36 months.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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 (25)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Children's Medical Center of Dallas
🇺🇸Dallas, Texas, United States
Children's Medical Center, University of California San Francisco
🇺🇸San Francisco, California, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Spectrum Health and DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
Texas Transplant Institute
🇺🇸San Antonio, Texas, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States