Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045513
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2002-09-06
Brief Title:
Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Phase III Study Of UCN-01 In Combination With Fludarabine In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-07
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 more than one drug may kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of combining UCN-01 with fludarabine in treating patients who have relapsed or refractory chronic lymphocytic leukemia or lymphocytic lymphoma
PURPOSE Phase III trial to study the effectiveness of combining UCN-01 with fludarabine in treating patients who have relapsed or refractory chronic lymphocytic leukemia or lymphocytic lymphoma
Detailed Description:
OBJECTIVES
Determine the overall response rate in patients with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma treated with UCN-01 and fludarabine
Assess the molecular changes in CLL cells in peripheral blood in patients treated with this regimen
Determine the progression-free and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of UCN-01
Patients receive UCN-01 IV over 3 hours on day 1 and fludarabine IV over 30-60 minutes on days 1-5 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 18-46 additional patients receive UCN-01 and fludarabine as above at the recommended phase II dose
PROJECTED ACCRUAL A total of 12 patients will be accrued for the phase I portion of this study within 6 months A total of 18-46 patients will be accrued for the phase II portion of this study within 9-23 months
Determine the overall response rate in patients with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma treated with UCN-01 and fludarabine
Assess the molecular changes in CLL cells in peripheral blood in patients treated with this regimen
Determine the progression-free and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of UCN-01
Patients receive UCN-01 IV over 3 hours on day 1 and fludarabine IV over 30-60 minutes on days 1-5 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 18-46 additional patients receive UCN-01 and fludarabine as above at the recommended phase II dose
PROJECTED ACCRUAL A total of 12 patients will be accrued for the phase I portion of this study within 6 months A total of 18-46 patients will be accrued for the phase II portion of this study within 9-23 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 |
|---|---|---|---|
| NCI-5538 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000256600 | REGISTRY | None | None |