Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003746
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
1999-11-01
Brief Title:
Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine CDA in Patients With Hairy Cell Leukemia
Status:
COMPLETED
Status Verified Date:
2012-05
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 It is not yet known if giving cladribine once a day is more effective than giving cladribine once a week in patients with hairy cell leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of cladribine given once a day to cladribine given once a week in treating patients with hairy cell leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of cladribine given once a day to cladribine given once a week in treating patients with hairy cell leukemia
Detailed Description:
OBJECTIVES
Compare the acute hematotoxicity and infection rate with daily and weekly administration of cladribine in patients with hairy cell leukemia
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive daily subcutaneous bolus injections of cladribine 2-CDA for 5 days standard dose
Arm II Patients receive weekly subcutaneous bolus injections of 2-CDA for 5 weeks
Patients showing complete or partial remission at evaluation on day 71 of the first treatment course do not receive any further treatment until relapse or disease progression is evident
Patients showing minor or no response on day 71 of the first treatment course receive a subsequent course of standard dose 2-CDA
Patients are followed every 3 months for 2 years then every 6 months thereafter
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study within 4 years
Compare the acute hematotoxicity and infection rate with daily and weekly administration of cladribine in patients with hairy cell leukemia
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive daily subcutaneous bolus injections of cladribine 2-CDA for 5 days standard dose
Arm II Patients receive weekly subcutaneous bolus injections of 2-CDA for 5 weeks
Patients showing complete or partial remission at evaluation on day 71 of the first treatment course do not receive any further treatment until relapse or disease progression is evident
Patients showing minor or no response on day 71 of the first treatment course receive a subsequent course of standard dose 2-CDA
Patients are followed every 3 months for 2 years then every 6 months thereafter
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| EU-98074 | None | None | None |
| SWS-SAKK-3298 | None | None | None |