Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450944
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2007-03-20
Brief Title:
Anti-CD19 and Anti-CD22 Immunotoxins in Treating Patients With Refractory or Relapsed B-Cell Acute Lymphoblastic Leukemia
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
A Phase I Study of Combination Therapy With Anti-CD19 and Anti-CD22 Immunotoxins Combotox in Adults With RefractoryRelapse Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2021-04
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:
RATIONALE Immunotoxins such as anti-CD19 and anti-CD22 can find cancer cells that express CD19 and CD22 and kill them without harming normal cells This may be an effective treatment for B-cell acute lymphoblastic leukemia
PURPOSE This phase I trial is studying the side effects and best dose of anti-CD19 and anti-CD22 immunotoxins in treating patients with refractory or relapsed B-cell acute lymphoblastic leukemia
PURPOSE This phase I trial is studying the side effects and best dose of anti-CD19 and anti-CD22 immunotoxins in treating patients with refractory or relapsed B-cell acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins Combotox in patients with refractory or relapsed B-cell acute lymphoblastic leukemia
Determine the toxicity of Combotox in these patients
Determine the pharmacokinetic PK profile of Combotox in these patients
Determine any antitumor activity of Combotox in terms of the percentage of blasts in bone marrow and peripheral blood
Determine the levels of human antimouse and human anti-dgA antibodies in patients treated with Combotox
Determine if there is a correlation between PK parameters and toxicity of Combotox in these patients
Determine if the expression of the CD19 and CD22 cell surface antigens is affected by Combotox
OUTLINE This is a dose-escalation study
Patients receive deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins Combotox IV over 4 hours on days 1 3 and 5 in the absence of disease progression or unacceptable toxicity
Cohorts of patients receive escalating doses of Combotox until the maximum tolerated dose is determined
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Determine the maximum tolerated dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins Combotox in patients with refractory or relapsed B-cell acute lymphoblastic leukemia
Determine the toxicity of Combotox in these patients
Determine the pharmacokinetic PK profile of Combotox in these patients
Determine any antitumor activity of Combotox in terms of the percentage of blasts in bone marrow and peripheral blood
Determine the levels of human antimouse and human anti-dgA antibodies in patients treated with Combotox
Determine if there is a correlation between PK parameters and toxicity of Combotox in these patients
Determine if the expression of the CD19 and CD22 cell surface antigens is affected by Combotox
OUTLINE This is a dose-escalation study
Patients receive deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins Combotox IV over 4 hours on days 1 3 and 5 in the absence of disease progression or unacceptable toxicity
Cohorts of patients receive escalating doses of Combotox until the maximum tolerated dose is determined
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA013330 | NIH | None | None |
| AECM-CCI-2005-536 | None | None | None |
| AECM-CCI-05-428 | None | None | None |
| AECM-MMC-05-10-265C | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA013330 |