Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072007
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2003-11-04
Brief Title:
Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With CLL
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
2-CDA and Rituximab as Remission Induction and Rituximab as In Vivo Purging Prior to Peripheral Stem Cell Mobilization in Patients With Chronic Lymphocytic Leukemia CLL - A Prospective Multicenter Phase II Trial
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 such as cladribine use different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining cladribine with rituximab may kill more cancer cells
PURPOSE This phase II trial is studying how well giving cladribine and rituximab as remission induction therapy together with rituximab and stem cell mobilization in treating patients with chronic lymphocytic leukemia
PURPOSE This phase II trial is studying how well giving cladribine and rituximab as remission induction therapy together with rituximab and stem cell mobilization in treating patients with chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy and tolerability of cladribine and rituximab as remission induction therapy in patients with chronic lymphocytic leukemia
Determine the complete remission rate in patients treated with this regimen
Secondary
Determine the very good partial remission rate and nodular partial remission rate in patients treated with this regimen
Determine the toxicity of this regimen in terms of hemotoxicity and infection rate in these patients
Determine the efficacy of in vivo purging with rituximab measured by immunophenotyping in these patients
Determine the feasibility of stem cell harvest in these patients after treatment with this induction therapy regimen and in vivo purging with rituximab
OUTLINE This is a multicenter study
Remission induction Patients receive cladribine subcutaneously SC on days 1-5 During courses 2-4 patients also receive rituximab IV on day 1 Treatment repeats every 28 days for up to 4 courses in the absence of unacceptable toxicity If unacceptable toxicity persists patients receive rituximab alone
Patients not achieving a complete remission CR very good partial remission VGPR or nodular partial remission NPR receive CHOP chemotherapy comprising cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral prednisone on days 1-5 Treatment repeats every 21 days for up to 4 courses or until patients achieve a CR VGPR or NPR
Patients achieving a CR VGPR or NPR proceed to stem cell mobilization and in vivo purging
Stem cell mobilization and in vivo purging Beginning 8-10 weeks after the first day of the last course of remission induction or CHOP patients receive rituximab IV on days 1 and 8 cyclophosphamide IV over 4 hours on day 2 and filgrastim G-CSF SC daily beginning on day 4 and continuing until the last day of apheresis Patients undergo apheresis on days 11-14
PROJECTED ACCRUAL A total of 17-41 patients will be accrued for this study within 3 years
Primary
Determine the efficacy and tolerability of cladribine and rituximab as remission induction therapy in patients with chronic lymphocytic leukemia
Determine the complete remission rate in patients treated with this regimen
Secondary
Determine the very good partial remission rate and nodular partial remission rate in patients treated with this regimen
Determine the toxicity of this regimen in terms of hemotoxicity and infection rate in these patients
Determine the efficacy of in vivo purging with rituximab measured by immunophenotyping in these patients
Determine the feasibility of stem cell harvest in these patients after treatment with this induction therapy regimen and in vivo purging with rituximab
OUTLINE This is a multicenter study
Remission induction Patients receive cladribine subcutaneously SC on days 1-5 During courses 2-4 patients also receive rituximab IV on day 1 Treatment repeats every 28 days for up to 4 courses in the absence of unacceptable toxicity If unacceptable toxicity persists patients receive rituximab alone
Patients not achieving a complete remission CR very good partial remission VGPR or nodular partial remission NPR receive CHOP chemotherapy comprising cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral prednisone on days 1-5 Treatment repeats every 21 days for up to 4 courses or until patients achieve a CR VGPR or NPR
Patients achieving a CR VGPR or NPR proceed to stem cell mobilization and in vivo purging
Stem cell mobilization and in vivo purging Beginning 8-10 weeks after the first day of the last course of remission induction or CHOP patients receive rituximab IV on days 1 and 8 cyclophosphamide IV over 4 hours on day 2 and filgrastim G-CSF SC daily beginning on day 4 and continuing until the last day of apheresis Patients undergo apheresis on days 11-14
PROJECTED ACCRUAL A total of 17-41 patients will be accrued for this study within 3 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-20321 | None | None | None |