Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290810
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2006-02-09
Brief Title:
Bevacizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Bevacizumab to Prevent or Delay Disease Progression in Patients With RelapsedRefractory Chronic Lymphocytic Leukemia CLL
Status:
COMPLETED
Status Verified Date:
2012-04
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 bevacizumab works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia Monoclonal antibodies such as bevacizumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer
Detailed Description:
PRIMARY OBJECTIVES
I Assess the treatment success rate of Bevacizumab in patients with relapsed or refractory B-cell chronic lymphocytic leukemia CLL
II Assess the toxicity associated with this regimen in patients with relapsed or refractory CLL
SECONDARY OBJECTIVES
I Assess sensitivity to apoptosiscell death of residual B-cell clone during therapy eg is treatment selecting out a resistant clone
II Evaluate if the risk stratification parameters ie immunoglobulin mutational ZAP-70 FISH defects and or CD38 status corresponds to both baseline apoptosiscell death and the rates of apoptosis of CLL B-cells when cultured with Bevacizumab
III Examine if Bevacizumab can be synergistic with other chemotherapeutic drugs such as chlorambucil or fludarabine
IV Assess if marrow vascularity is increased at entry to study and if it is modulated following therapy with Bevacizumab
V Examine the association of VEGF plasma levels at baseline with clinical responses to Bevacizumab
VI Examine the levels of VCAM at entry to the study and during treatment with Bevacizumab
OUTLINE This is a multicenter study Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity After completion of study treatment patients are followed periodically for up to 5 years
I Assess the treatment success rate of Bevacizumab in patients with relapsed or refractory B-cell chronic lymphocytic leukemia CLL
II Assess the toxicity associated with this regimen in patients with relapsed or refractory CLL
SECONDARY OBJECTIVES
I Assess sensitivity to apoptosiscell death of residual B-cell clone during therapy eg is treatment selecting out a resistant clone
II Evaluate if the risk stratification parameters ie immunoglobulin mutational ZAP-70 FISH defects and or CD38 status corresponds to both baseline apoptosiscell death and the rates of apoptosis of CLL B-cells when cultured with Bevacizumab
III Examine if Bevacizumab can be synergistic with other chemotherapeutic drugs such as chlorambucil or fludarabine
IV Assess if marrow vascularity is increased at entry to study and if it is modulated following therapy with Bevacizumab
V Examine the association of VEGF plasma levels at baseline with clinical responses to Bevacizumab
VI Examine the levels of VCAM at entry to the study and during treatment with Bevacizumab
OUTLINE This is a multicenter study Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity After completion of study treatment patients are followed periodically for up to 5 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-2009-00137 | REGISTRY | None | None |
| MAYO-MC048C | None | None | None |
| NCI-7211 | None | None | None |
| CDR0000459933 | None | None | None |
| MC048C | OTHER | None | None |
| 7211 | OTHER | None | None |
| P30CA015083 | NIH | None | None |
| N01CM62205 | NIH | None | None |
| N01CM62207 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62207 |