Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002833
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
1999-11-01
Brief Title:
Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis
Status:
COMPLETED
Status Verified Date:
2012-07
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine the toxic effects and feasibility of using filgrastim in promoting hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage chemotherapy II Determine the engraftment kinetics and degree of chimerism achievable
OUTLINE The trial will have 2 patient groups Patients not in remission are assigned to group 1 while patients in remission are assigned to group 2 Then groups are divided into 2 treatment arms Patients failing fludarabine therapy receive cytarabine Ara-C IV over 2 hours on days -7 -6 -5 -4 and -3 Beginning 4 hours before the first dose of Ara-C patients receive cladribine 2-chlorodeoxyadenosine 2-CdA by continuous infusion for 5 days Patients without prior fludarabine therapy receive fludarabine IV over 30 minutes daily on days -6 -5 -4 and -3 Ara-C IV begins 4 hours after the beginning of the fludarabine infusion and continues for 4 hours Idarubicin IV is given on days -6 -5 and -4 Donors receive filgrastim SC every 12 hours for 2 days prior to stem cell collection Cells are infused on day 0 For GVHD prophylaxis all patients receive cyclosporine via continuous IV infusion Oral cyclosporine is administered once patients tolerate oral feeding and continued for 6 months postinfusion Then the dose of cyclosporine is tapered 10 weekly until discontinued Methylprednisolone begins 5 days after infusion and is gradually tapered
PROJECTED ACCRUAL A maximum of 15 patients per arm are likely to be entered in 24 to 36 months
OUTLINE The trial will have 2 patient groups Patients not in remission are assigned to group 1 while patients in remission are assigned to group 2 Then groups are divided into 2 treatment arms Patients failing fludarabine therapy receive cytarabine Ara-C IV over 2 hours on days -7 -6 -5 -4 and -3 Beginning 4 hours before the first dose of Ara-C patients receive cladribine 2-chlorodeoxyadenosine 2-CdA by continuous infusion for 5 days Patients without prior fludarabine therapy receive fludarabine IV over 30 minutes daily on days -6 -5 -4 and -3 Ara-C IV begins 4 hours after the beginning of the fludarabine infusion and continues for 4 hours Idarubicin IV is given on days -6 -5 and -4 Donors receive filgrastim SC every 12 hours for 2 days prior to stem cell collection Cells are infused on day 0 For GVHD prophylaxis all patients receive cyclosporine via continuous IV infusion Oral cyclosporine is administered once patients tolerate oral feeding and continued for 6 months postinfusion Then the dose of cyclosporine is tapered 10 weekly until discontinued Methylprednisolone begins 5 days after infusion and is gradually tapered
PROJECTED ACCRUAL A maximum of 15 patients per arm are likely to be entered in 24 to 36 months
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 |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-DM-94078 | OTHER | None | None |
| NCI-G96-1001 | None | None | None |
| CDR0000065035 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |