Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003913
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
1999-11-01
Brief Title:
Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Nonmalignant Hematologic Disease
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Multicenter Study of Unrelated Umbilical Cord Blood as an Alternate Source of Stem Cells for Transplantation
Status:
COMPLETED
Status Verified Date:
2010-03
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 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
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 26 vs 36 vs 46 vs 56 or 66 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 metabolismstorage 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
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 26 vs 36 vs 46 vs 56 or 66 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 metabolismstorage 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
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 |
|---|---|---|---|
| CDR0000067092 | REGISTRY | PDQ | None |
| FHCRC-133000 | None | None | None |
| UMN-MT-9817 | None | None | None |
| NCI-G99-1523 | None | None | None |