Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412594
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2006-12-14
Brief Title:
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of 2-Chlorodeoxyadenosine 2CDA Followed by Rituximab in Hairy Cell Leukemia
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia Drugs used in chemotherapy such as cladribine work in different ways to stop the growth of cancer cells either by killing the cells by stopping them from dividing or by stopping them from spreading Immunotherapy with monoclonal antibodies such as rituximab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Giving cladribine together with rituximab may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To demonstrate the efficacy in achieving complete response of combination of cladribine administered intravenously over 2 hours for 5 days followed by rituximab weekly for 8 weeks in patients with untreated or previously treated hairy cell leukemia
II To examine the efficacy of rituximab to eradicate minimal residual disease MRD after cladribine therapy as assessed by immunophenotyping of bone marrow and peripheral blood
III To examine the effect of addition of rituximab to cladribine on the long term disease-free DFS and overall survival OS as compared with historical controls
IV To evaluate potential predictors of outcome including molecular and flow evaluations of MRD as well as other potential molecular predictors such as v-raf murine sarcoma viral oncogene homolog B1 BRAF
OUTLINE
Patients receive cladribine intravenously IV over 2 hours once daily QD on days 1-5 and rituximab IV once weekly for 8 weeks beginning on day 28 in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year
I To demonstrate the efficacy in achieving complete response of combination of cladribine administered intravenously over 2 hours for 5 days followed by rituximab weekly for 8 weeks in patients with untreated or previously treated hairy cell leukemia
II To examine the efficacy of rituximab to eradicate minimal residual disease MRD after cladribine therapy as assessed by immunophenotyping of bone marrow and peripheral blood
III To examine the effect of addition of rituximab to cladribine on the long term disease-free DFS and overall survival OS as compared with historical controls
IV To evaluate potential predictors of outcome including molecular and flow evaluations of MRD as well as other potential molecular predictors such as v-raf murine sarcoma viral oncogene homolog B1 BRAF
OUTLINE
Patients receive cladribine intravenously IV over 2 hours once daily QD on days 1-5 and rituximab IV once weekly for 8 weeks beginning on day 28 in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2004-0223 | OTHER | M D Anderson Cancer Center | httpsreporternihgovquickSearchP30CA016672 |
| NCI-2012-01394 | REGISTRY | None | None |