Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053027
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2003-01-27
Brief Title:
Rituximab and Cladribine in Treating Patients With Newly Diagnosed Non-Hodgkins Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Rituximab and 2-Chlorodeoxyadenosine 2-CDA in Newly Diagnosed Mantle Cell Lymphoma MCL
Status:
COMPLETED
Status Verified Date:
2016-12
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 Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy such as cladribine work in different ways to stop cancer cells from dividing so they stop growing or die Combining rituximab with cladribine may kill more cancer cells
PURPOSE This phase II trial is studying how well giving rituximab together with cladribine works in treating patients with newly-diagnosed mantle cell lymphoma
PURPOSE This phase II trial is studying how well giving rituximab together with cladribine works in treating patients with newly-diagnosed mantle cell lymphoma
Detailed Description:
OBJECTIVES
Determine whether rituximab and cladribine will increase the complete remission rate and the unconfirmed complete remission rate in patients with mantle cell lymphoma
Determine the time to progression in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
An initial cohort of 6 patients at Mayo Clinic receives rituximab IV over 4-8 hours on day 1 and cladribine IV over 2 hours on days 4-8 If 2 or more patients experience unacceptable toxicity during the first course the study is discontinued otherwise the study is opened for enrollment at all NCCTG sites The phase II study is open for enrollment as of 51404
Treatment repeats every 28 days for a total of 2-6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually for 2 years
Determine whether rituximab and cladribine will increase the complete remission rate and the unconfirmed complete remission rate in patients with mantle cell lymphoma
Determine the time to progression in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
An initial cohort of 6 patients at Mayo Clinic receives rituximab IV over 4-8 hours on day 1 and cladribine IV over 2 hours on days 4-8 If 2 or more patients experience unacceptable toxicity during the first course the study is discontinued otherwise the study is opened for enrollment at all NCCTG sites The phase II study is open for enrollment as of 51404
Treatment repeats every 28 days for a total of 2-6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually for 2 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 |
|---|---|---|---|
| NCI-2012-02510 | REGISTRY | None | None |
| CDR0000269055 | REGISTRY | PDQ Physician Data Query | None |