Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398112
Status:
COMPLETED
Last Update Posted:
2014-05-14
First Post:
2006-11-09
Brief Title:
Sunitinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Sunitinib Malate for Treatment of Patients With RelapsedRefractory Chronic Lymphocytic Leukemia CLL or Small Lymphocytic Lymphoma SLL
Status:
COMPLETED
Status Verified Date:
2012-12
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:
This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer
Detailed Description:
PRIMARY OBJECTIVES
I Assess the response rate complete response CR and partial response in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with sunitinib malate
II Assess the toxicity of this drug in these patients III Assess duration of response time to progression overall survival and CR rate in patients treated with this drug
SECONDARY OBJECTIVES
I Evaluate if known risk stratification parameters ie immunoglobulin mutational status ZAP-70 status fluorescent in situ hybridization FISH defects andor CD38 status are related to clinical response to sunitinib malate
OUTLINE This is a multicenter study
Patients receive oral sunitinib malate daily on days 1-28 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Patients undergo blood collection periodically for translational and pharmacological studies including IgVH gene mutation status and ZAP-70 status Samples are examined by fluorescent in situ hybridization FISH and other assays
After completion of study treatment patients are followed every 3 months for up to 2 years
I Assess the response rate complete response CR and partial response in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with sunitinib malate
II Assess the toxicity of this drug in these patients III Assess duration of response time to progression overall survival and CR rate in patients treated with this drug
SECONDARY OBJECTIVES
I Evaluate if known risk stratification parameters ie immunoglobulin mutational status ZAP-70 status fluorescent in situ hybridization FISH defects andor CD38 status are related to clinical response to sunitinib malate
OUTLINE This is a multicenter study
Patients receive oral sunitinib malate daily on days 1-28 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Patients undergo blood collection periodically for translational and pharmacological studies including IgVH gene mutation status and ZAP-70 status Samples are examined by fluorescent in situ hybridization FISH and other assays
After completion of study treatment patients are followed every 3 months for up to 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-2012-01830 | REGISTRY | None | None |
| NCCTG-N0683 | None | None | None |
| CDR0000512979 | None | None | None |
| N0683 | OTHER | None | None |
| N0683 | OTHER | None | None |
| U10CA025224 | NIH | CTEP | httpsreporternihgovquickSearchU10CA025224 |