Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002788
Status:
COMPLETED
Last Update Posted:
2010-09-15
First Post:
2000-08-03
Brief Title:
High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A PILOT STUDY OF TOTAL BODY IRRADIATION AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS TRANSPLANTATION WITH CD34 SELECTED PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Status:
COMPLETED
Status Verified Date:
2010-09
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 Radiation therapy uses high-energy x-rays to damage cancer cells Combining chemotherapy and radiation therapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of high-dose combination chemotherapy followed by total-body irradiation and peripheral stem cell transplantation in treating patients with chronic lymphocytic leukemia
PURPOSE Phase I trial to study the effectiveness of high-dose combination chemotherapy followed by total-body irradiation and peripheral stem cell transplantation in treating patients with chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES I Evaluate engraftment after autografting with CD34 selected peripheral blood stem cells PBSC in patients with chronic lymphocytic leukemia CLL II Evaluate the efficacy of CD34 selection for purging CLL from PBSC collection III Determine the effectiveness of mobilization chemotherapy with cyclophosphamide etoposide and dexamethasone plus filgrastim granulocyte colony-stimulating factor to mobilize PBSC in these patients IV Describe toxicity and disease response to a conditioning regimen of total body irradiation and cyclophosphamide in these patients
OUTLINE There are 3 phases to the treatment plan Cytoreductive chemotherapy can be given by conventional chemotherapy Patients are treated until at least a good partial remission Patients will have CD34 selected peripheral blood stem cells PBSC stored after treatment with mobilization chemotherapy followed by filgrastim granulocyte colony-stimulating factor G-CSF Cyclosphosphamide CTX IV is given over 1 hour Etoposide VP-16 is given over 1-2 hours on day 2 Dexamethasone is given 4 times a day on days 1-3 G-CSF is given subcutaneously daily beginning 2 days after chemotherapy and continuing until PBSC collection is completed At least 4 weeks should ensue after mobilization chemotherapy before proceeding with the transplant Patients are treated with TBI on days -6 -5 and -4 and CTX on days -3 and -2 PBSC are infused on day 0
PROJECTED ACCRUAL A total of 15 patients will be entered in this study
OUTLINE There are 3 phases to the treatment plan Cytoreductive chemotherapy can be given by conventional chemotherapy Patients are treated until at least a good partial remission Patients will have CD34 selected peripheral blood stem cells PBSC stored after treatment with mobilization chemotherapy followed by filgrastim granulocyte colony-stimulating factor G-CSF Cyclosphosphamide CTX IV is given over 1 hour Etoposide VP-16 is given over 1-2 hours on day 2 Dexamethasone is given 4 times a day on days 1-3 G-CSF is given subcutaneously daily beginning 2 days after chemotherapy and continuing until PBSC collection is completed At least 4 weeks should ensue after mobilization chemotherapy before proceeding with the transplant Patients are treated with TBI on days -6 -5 and -4 and CTX on days -3 and -2 PBSC are infused on day 0
PROJECTED ACCRUAL A total of 15 patients will be entered in this study
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 |
|---|---|---|---|
| CDR0000064852 | REGISTRY | PDQ | None |
| FHCRC-96200 | None | None | None |
| NCI-H96-0925 | None | None | None |