Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002792
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
ALLOGENEIC MARROW OR PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR AGNOGENIC MYELOID METAPLASIA WITH MYELOFIBROSIS
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 tumor cells from dividing so they stop growing or die Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus either bone marrow or peripheral stem cell transplantation in treating patients with myeloproliferative disorders
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus either bone marrow or peripheral stem cell transplantation in treating patients with myeloproliferative disorders
Detailed Description:
OBJECTIVES
Assess disease free survival in patients with idiopathic myelofibrosis treated with a preparative busulfancyclophosphamide regimen followed by allogeneic bone marrow or peripheral blood stem cell transplantation
Determine the risk of primary graft failure in these patients
OUTLINE Patients receive a preparative regimen consisting of oral busulfan every 6 hours on days -7 through -4 and cyclophosphamide on days -3 and -2 Patients then receive allogeneic bone marrow or peripheral blood stem cells on day 0 Patients registered on protocol FHCRC-110600 randomized to stem cell transplant receive unmodified G-CSF-mobilized stem cells from an HLA-identical donor
Patients receive cyclosporinemethotrexate or tacrolimusmethotrexate as prophylaxis for graft-versus-host disease GVHD Patients receiving marrow from unrelated donors are eligible for appropriate GVHD prophylaxis studies
Patients are followed at 6 and 12 months after transplant
PROJECTED ACCRUAL A maximum of 20 patients will be accrued for this study over approximately 35 years
Assess disease free survival in patients with idiopathic myelofibrosis treated with a preparative busulfancyclophosphamide regimen followed by allogeneic bone marrow or peripheral blood stem cell transplantation
Determine the risk of primary graft failure in these patients
OUTLINE Patients receive a preparative regimen consisting of oral busulfan every 6 hours on days -7 through -4 and cyclophosphamide on days -3 and -2 Patients then receive allogeneic bone marrow or peripheral blood stem cells on day 0 Patients registered on protocol FHCRC-110600 randomized to stem cell transplant receive unmodified G-CSF-mobilized stem cells from an HLA-identical donor
Patients receive cyclosporinemethotrexate or tacrolimusmethotrexate as prophylaxis for graft-versus-host disease GVHD Patients receiving marrow from unrelated donors are eligible for appropriate GVHD prophylaxis studies
Patients are followed at 6 and 12 months after transplant
PROJECTED ACCRUAL A maximum of 20 patients will be accrued for this study over approximately 35 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 |
|---|---|---|---|
| FHCRC-103201 | None | None | None |
| NCI-H96-0929 | None | None | None |
| CDR0000064859 | REGISTRY | PDQ | None |