Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002638
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Relapsed Acute Lymphocytic Leukemia
Sponsor:
University of Nebraska
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA
Status:
COMPLETED
Status Verified Date:
2002-09
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 combination chemotherapy followed by peripheral stem cell transplantation in treating children who have relapsed acute lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have relapsed acute lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the efficacy of autologous peripheral blood stem cell PBSC transplantation for marrow reconstitution after high-dose carmustine cytarabine etoposide and cyclophosphamide in children with relapsed acute lymphocytic leukemia
Determine the dose effect of autologous PBSC on engraftment in this patient population
OUTLINE Patients receive chemotherapy mobilization comprising cytarabine IV every 12 hours on days 1-5 When blood counts recover autologous peripheral blood stem cells PBSC are harvested and selected for mononuclear cells granulocyte-macrophage colony-forming units and CD34 cells
Patients receive preparative regimen comprising carmustine IV on days -8 and -3 cytarabine IV every 12 hours and etoposide IV every 12 hours on days -7 to -4 and cyclophosphamide IV on days -2 and -1 PBSC are reinfused on day 0 Patients receive filgrastim G-CSF or sargramostim GM-CSF beginning after PBSC transplantation Male patients undergo radiotherapy to the testes before transplantation Patients with a history of CNS leukemia undergo craniospinal irradiation before transplantation
Patients are followed at 100 days 6 months and 1 year
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study within 5 years
Determine the efficacy of autologous peripheral blood stem cell PBSC transplantation for marrow reconstitution after high-dose carmustine cytarabine etoposide and cyclophosphamide in children with relapsed acute lymphocytic leukemia
Determine the dose effect of autologous PBSC on engraftment in this patient population
OUTLINE Patients receive chemotherapy mobilization comprising cytarabine IV every 12 hours on days 1-5 When blood counts recover autologous peripheral blood stem cells PBSC are harvested and selected for mononuclear cells granulocyte-macrophage colony-forming units and CD34 cells
Patients receive preparative regimen comprising carmustine IV on days -8 and -3 cytarabine IV every 12 hours and etoposide IV every 12 hours on days -7 to -4 and cyclophosphamide IV on days -2 and -1 PBSC are reinfused on day 0 Patients receive filgrastim G-CSF or sargramostim GM-CSF beginning after PBSC transplantation Male patients undergo radiotherapy to the testes before transplantation Patients with a history of CNS leukemia undergo craniospinal irradiation before transplantation
Patients are followed at 100 days 6 months and 1 year
PROJECTED ACCRUAL Approximately 30 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 |
|---|---|---|---|
| CDR0000064114 | REGISTRY | None | None |
| NCI-V95-0639 | Registry Identifier | PDQ Physician Data Query | None |