Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074048
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2003-12-10
Brief Title:
BL22 Immunotoxin in Treating Patients Previously Treated With Cladribine for Hairy Cell Leukemia
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia
Status:
COMPLETED
Status Verified Date:
2010-06
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:
RATIONALE The BL22 immunotoxin can locate tumor cells and kill them without harming normal cells This may be an effective treatment for hairy cell leukemia that has not responded to treatment with cladribine
PURPOSE This phase II trial is studying BL22 immunotoxin to see how well it works in treating patients previously treated with cladribine for hairy cell leukemia
PURPOSE This phase II trial is studying BL22 immunotoxin to see how well it works in treating patients previously treated with cladribine for hairy cell leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with cladribine-resistant hairy cell leukemia treated with BL22 immunotoxin
Secondary
Determine the response duration in patients treated with this drug
Determine the safety of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Correlate BL22 blood levels and toxicity of this drug with the development of neutralizing antibodies in these patients
OUTLINE Patients receive BL22 immunotoxin IV over 30 minutes on days 1 3 and 5 followed by rest
Patients are then evaluated at 8 weeks Patients achieving complete hematologic remission are followed All other patients continue to receive BL22 immunotoxin as above on days 1 3 and 5 Treatment repeats every 4 weeks for up to a total of 16 courses in the absence of disease progression or unacceptable toxicity Patients achieving CR without minimal residual disease MRD receive 2 courses beyond CR Patients achieving CR with MRD receive 4 courses beyond CR
Patients are followed every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 3 years
Primary
Determine the response rate in patients with cladribine-resistant hairy cell leukemia treated with BL22 immunotoxin
Secondary
Determine the response duration in patients treated with this drug
Determine the safety of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Correlate BL22 blood levels and toxicity of this drug with the development of neutralizing antibodies in these patients
OUTLINE Patients receive BL22 immunotoxin IV over 30 minutes on days 1 3 and 5 followed by rest
Patients are then evaluated at 8 weeks Patients achieving complete hematologic remission are followed All other patients continue to receive BL22 immunotoxin as above on days 1 3 and 5 Treatment repeats every 4 weeks for up to a total of 16 courses in the absence of disease progression or unacceptable toxicity Patients achieving CR without minimal residual disease MRD receive 2 courses beyond CR Patients achieving CR with MRD receive 4 courses beyond CR
Patients are followed every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 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 |
|---|---|---|---|
| NCI-04-C-0014 | None | None | None |
| NCI-6048 | None | None | None |