Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055653
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2003-03-06
Brief Title:
Donor Umbilical Cord Blood Transplantation in Treating Patients With Leukemia Lymphoma or Nonmalignant Hematologic Disorders
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Unrelated Umbilical Cord Blood As An Alternate Source Of Stem Cells Transplantation
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 56 or 66 HLA match age 18 and under
Stratum II Malignant disease 46 HLA match age 18 and under
Stratum III Malignant disease 36 HLA match age 18 and under
Stratum IV Malignant disease 26 or 16 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 metabolismstorage 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 metabolismstorage 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
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 56 or 66 HLA match age 18 and under
Stratum II Malignant disease 46 HLA match age 18 and under
Stratum III Malignant disease 36 HLA match age 18 and under
Stratum IV Malignant disease 26 or 16 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 metabolismstorage 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 metabolismstorage 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-DS-00-22 | None | None | None |