Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT00438958
Status:
COMPLETED
Last Update Posted:
2014-03-05
First Post:
2007-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sibling Donor Peripheral Stem Cell Transplant or Sibling Donor Bone Marrow Transplant in Treating Patients With Hematologic Cancers or Other Diseases
Sponsor:
The Canadian Blood and Marrow Transplant Group
Organization:
Study Overview
Official Title:
A Randomized Multicentre Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation for Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2009-07
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: Giving chemotherapy before a donor peripheral stem cell transplant or bone marrow transplant using stem cells from a brother or sister that closely match the patient's stem cells, helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving colony-stimulating factors, such as G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored. Giving methotrexate and cyclosporine before and after transplant may stop this from happening. It is not yet known whether a donor peripheral stem cell transplant is more effective than a donor bone marrow transplant in treating hematologic cancers or other diseases.
PURPOSE: This randomized phase III trial is studying filgrastim-mobilized sibling donor peripheral stem cell transplant to see how well it works compared with sibling donor bone marrow transplant in treating patients with hematologic cancers or other diseases.
PURPOSE: This randomized phase III trial is studying filgrastim-mobilized sibling donor peripheral stem cell transplant to see how well it works compared with sibling donor bone marrow transplant in treating patients with hematologic cancers or other diseases.
Detailed Description:
OBJECTIVES:
Primary
* Compare the time to treatment failure in patients with hematologic malignancies or other diseases treated with filgrastim (G-CSF)-mobilized matched-sibling donor peripheral blood stem cell transplantation vs G-CSF-stimulated matched-sibling donor bone marrow transplantation.
Secondary
* Compare the hematological recovery and overall survival of patients treated with these regimens.
* Compare the quality of life, in terms of extensive graft-versus-host disease (GVHD), in patients treated with these regimens.
* Compare the economic impact associated with these treatment regimens.
Tertiary
* Compare the incidence and severity of acute GVHD in patients treated with these regimens.
* Compare organ involvement, symptomatology, and functional impact of chronic GVHD in patients treated with these regimens.
* Compare disease-free survival of patients treated with these regimens.
* Compare donor quality of life.
* Compare cost analysis, from a societal perspective, of these treatment regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to treatment center, disease (chronic myelogenous leukemia vs acute myeloid leukemia vs myelodysplastic syndromes vs other hematologic malignancy), disease stage (early disease vs late disease), and conditioning regimen (busulfan and cyclophosphamide vs cyclophosphamide and total body irradiation vs other).
* Myeloablative conditioning regimen: Patients receive a myeloablative conditioning regimen that has been approved by the clinical chair.
* Stem cell transplantation (SCT): Patients are randomized to 1 of 2 SCT arms.
* Arm I: Patients undergo sibling donor filgrastim (G-CSF)-mobilized peripheral blood SCT on day 0.
* Arm II: Patients undergo sibling donor G-CSF- mobilized bone marrow transplantation on day 0.
* Graft-verus-host disease (GVHD) treatment: Patients receive methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV (or orally) every 12 hours beginning on day -2 and continuing until day 100.
Quality of life is assessed at baseline and at 1 and 3 years post-transplantation.
After completion of study therapy, patients are followed periodically for at least 4 years.
PROJECTED ACCRUAL: A total of 230 patients will be accrued for this study.
Primary
* Compare the time to treatment failure in patients with hematologic malignancies or other diseases treated with filgrastim (G-CSF)-mobilized matched-sibling donor peripheral blood stem cell transplantation vs G-CSF-stimulated matched-sibling donor bone marrow transplantation.
Secondary
* Compare the hematological recovery and overall survival of patients treated with these regimens.
* Compare the quality of life, in terms of extensive graft-versus-host disease (GVHD), in patients treated with these regimens.
* Compare the economic impact associated with these treatment regimens.
Tertiary
* Compare the incidence and severity of acute GVHD in patients treated with these regimens.
* Compare organ involvement, symptomatology, and functional impact of chronic GVHD in patients treated with these regimens.
* Compare disease-free survival of patients treated with these regimens.
* Compare donor quality of life.
* Compare cost analysis, from a societal perspective, of these treatment regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to treatment center, disease (chronic myelogenous leukemia vs acute myeloid leukemia vs myelodysplastic syndromes vs other hematologic malignancy), disease stage (early disease vs late disease), and conditioning regimen (busulfan and cyclophosphamide vs cyclophosphamide and total body irradiation vs other).
* Myeloablative conditioning regimen: Patients receive a myeloablative conditioning regimen that has been approved by the clinical chair.
* Stem cell transplantation (SCT): Patients are randomized to 1 of 2 SCT arms.
* Arm I: Patients undergo sibling donor filgrastim (G-CSF)-mobilized peripheral blood SCT on day 0.
* Arm II: Patients undergo sibling donor G-CSF- mobilized bone marrow transplantation on day 0.
* Graft-verus-host disease (GVHD) treatment: Patients receive methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV (or orally) every 12 hours beginning on day -2 and continuing until day 100.
Quality of life is assessed at baseline and at 1 and 3 years post-transplantation.
After completion of study therapy, patients are followed periodically for at least 4 years.
PROJECTED ACCRUAL: A total of 230 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CBMTG-0601 | None | None | View |