Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089154
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2004-08-04
Brief Title:
Apolizumab 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 Thrice Weekly Apolizumab in Patients With Chronic Lymphocytic Leukemia CRC Master Protocol
Status:
COMPLETED
Status Verified Date:
2013-06
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 apolizumab works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma Monoclonal antibodies such as apolizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate and progression-free survival rate in patients with relapsed or refractory chronic lymphocytic leukemia CLL or noncontiguous stage II or stage III or IV small lymphocytic lymphoma treated with apolizumab
II Determine the safety of this drug in terms of the frequency and severity of treatment-related adverse events in these patients
SECONDARY OBJECTIVES
I Determine clinical response to apolizumab varies by genetic subtype of CLL II Determine if pharmacokinetic clearance is truly predicted by 1D10 antigen density on the individual patient CLL cell and how apolizumab clearance correlates with response and selected toxicities observed
III To determine the importance of reactive oxygen species and specific signaling pathways in promoting apolizumab-mediated apoptosis in vitro and in vivo in primary CLL cells and if this correlates with clinical response to therapy
IV To determine the cellular properties which convey resistance to apolizumab in CLL in vivo
OUTLINE This is a multicenter study
Patients receive apolizumab IV over 2-4 hours on days 1 2 3 5 8 10 12 15 17 19 22 24 and 26 in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 week at 1 and 2 months every 3 months for 1 year and then every 6 months for 3 years
I Determine the response rate and progression-free survival rate in patients with relapsed or refractory chronic lymphocytic leukemia CLL or noncontiguous stage II or stage III or IV small lymphocytic lymphoma treated with apolizumab
II Determine the safety of this drug in terms of the frequency and severity of treatment-related adverse events in these patients
SECONDARY OBJECTIVES
I Determine clinical response to apolizumab varies by genetic subtype of CLL II Determine if pharmacokinetic clearance is truly predicted by 1D10 antigen density on the individual patient CLL cell and how apolizumab clearance correlates with response and selected toxicities observed
III To determine the importance of reactive oxygen species and specific signaling pathways in promoting apolizumab-mediated apoptosis in vitro and in vivo in primary CLL cells and if this correlates with clinical response to therapy
IV To determine the cellular properties which convey resistance to apolizumab in CLL in vivo
OUTLINE This is a multicenter study
Patients receive apolizumab IV over 2-4 hours on days 1 2 3 5 8 10 12 15 17 19 22 24 and 26 in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 week at 1 and 2 months every 3 months for 1 year and then every 6 months for 3 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 |
|---|---|---|---|
| R21CA091564 | NIH | None | httpsreporternihgovquickSearchR21CA091564 |
| OSU 0410 | None | None | None |
| CLLRC-OSU-0410 | None | None | None |
| CDR0000378072 | None | None | None |
| OSU-0410 | None | None | None |
| NCI-6257 | None | None | None |