Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002879
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
1999-11-01
Brief Title:
Cladribine in Patients With Mantle Cell Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A PHASE II TRIAL OF 2-CDA IN PREVIOUSLY TREATED OR UNTREATED PATIENTS WITH 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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effects of cladribine in previously treated or untreated patients with mantle cell lymphoma
PURPOSE Phase II trial to study the effects of cladribine in previously treated or untreated patients with mantle cell lymphoma
Detailed Description:
OBJECTIVES I Determine the efficacy of cladribine 2-chlorodeoxyadenosine 2-CdA as treatment for mantle cell lymphoma MCL either as initial therapy or for relapsedrefractory disease II Determine by flow cytometry immunophenotyping of blood lymphocytes the number of patients with peripheral blood involvement at the time of diagnosis and compare the presence or absence of peripheral blood involvement with response data III Detect rearrangements involving the bcl-1 gene and immunoglobulin heavy chain locus by molecular techniques eg polymerase chain reaction Southern blotting or in situ hybridization and compare these results with immunohistochemical demonstration of bcl-1 protein expression VI Determine the proliferative rate of MCL by immunohistochemistry and DNA content flow cytometry V Summarize the toxic effects associated with this treatment
OUTLINE Patients receive cladribine 2-chlorodeoxyadenosine 2-CdA daily for 5 days every 4 weeks for a maximum of 6 courses response is assessed after every 2 courses Patients in complete remission or with stable disease discontinue treatment and are followed those with disease progression at any time are removed from study Patients are followed every 2 months for 1 year every 4 months for 1 year every 6 months for 1 year and annually for 2 years
OUTLINE Patients receive cladribine 2-chlorodeoxyadenosine 2-CdA daily for 5 days every 4 weeks for a maximum of 6 courses response is assessed after every 2 courses Patients in complete remission or with stable disease discontinue treatment and are followed those with disease progression at any time are removed from study Patients are followed every 2 months for 1 year every 4 months for 1 year every 6 months for 1 year and 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-2012-02249 | REGISTRY | None | None |
| CDR0000065179 | REGISTRY | PDQ Physician Data Query | None |