Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002768
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
AUTOLOGOUS STEM CELL TRANSPLANTATION FOR ACUTE MYELOID LEUKEMIA IN SECOND REMISSION A PHASE II STUDY
Status:
COMPLETED
Status Verified Date:
2016-06
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
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation following chemotherapy in treating patients with acute myeloid leukemia in second remission
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation following chemotherapy in treating patients with acute myeloid leukemia in second remission
Detailed Description:
OBJECTIVES I Determine the ability of mobilization using cytarabine etoposide and filgrastim G-CSF conditioning using busulfan and etoposide and autologous peripheral blood stem cell transplantation to generate a 2-year disease-free survival rate in at least 30 of patients with acute myeloid leukemia AML in second complete remission II Determine whether the treatment-related mortality can be limited to less than 20 in patients treated with this regimen III Determine whether adequate numbers of PBSC can be collected in these patients IV Determine the engraftment kinetics of primed PBSC obtained from these patients
OUTLINE Mobilizationharvest Patients receive cytarabine IV over 2 hours every 12 hours and etoposide IV continuously on days 1-4 Filgrastim G-CSF is administered subcutaneously SC beginning on day 14 and continuing until peripheral blood stem cells PBSC are harvested When blood counts recover PBSC are harvested and selected for CD34 cells Conditioning Beginning at least 4 weeks after hospital discharge for mobilization and harvest and when blood counts recover patients receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 4 hours on day -3 PBSC are reinfused on day 0 G-CSF is administered SC beginning on day 0 and continuing until blood counts recover Patients with documented CNS disease at first relapse receive methotrexate intrathecally at intervals of 1 week or greater before andor after PBSC transplantation for a total of 6 doses Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 26-48 patients will be accrued within 2 years
OUTLINE Mobilizationharvest Patients receive cytarabine IV over 2 hours every 12 hours and etoposide IV continuously on days 1-4 Filgrastim G-CSF is administered subcutaneously SC beginning on day 14 and continuing until peripheral blood stem cells PBSC are harvested When blood counts recover PBSC are harvested and selected for CD34 cells Conditioning Beginning at least 4 weeks after hospital discharge for mobilization and harvest and when blood counts recover patients receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 4 hours on day -3 PBSC are reinfused on day 0 G-CSF is administered SC beginning on day 0 and continuing until blood counts recover Patients with documented CNS disease at first relapse receive methotrexate intrathecally at intervals of 1 week or greater before andor after PBSC transplantation for a total of 6 doses Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 26-48 patients will be accrued within 2 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 |
|---|---|---|---|
| CDR0000064734 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-9620 | None | None | None |