Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077493
Status:
SUSPENDED
Last Update Posted:
2007-12-28
First Post:
2004-02-10
Brief Title:
BL22 Immunotoxin In Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkins Lymphoma
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
Pediatric Phase I Trial of BL22 for Refractory CD22-Positive Leukemias and Lymphomas
Status:
SUSPENDED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
protocol development and Amended protocol revision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE BL22 immunotoxin can locate tumor cells and kill them without harming normal cells BL22 immunotoxin may be effective in treating relapsed or refractory acute lymphoblastic leukemia and non-Hodgkins lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating young patients with relapsed or refractory acute lymphoblastic leukemia or non-Hodgkins lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating young patients with relapsed or refractory acute lymphoblastic leukemia or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the toxic effects of BL22 immunotoxin in pediatric patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia or non-Hodgkins lymphoma
Determine the maximum tolerated dose of this drug in these patients
Determine the immunogenicity of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Secondary
Determine the in vitro cytotoxicity of this drug against lymphoblasts from patients with acute lymphoblastic leukemia
Determine the therapeutic efficacy of this drug in inducing remissions in these patients
Determine changes in lymphocyte subsets immunoglobulin levels serum cytokines and soluble cytokine receptor levels in patients treated with this drug
OUTLINE This is a non-randomized dose-escalation study
Patients receive BL22 immunotoxin IV over 30 minutes on days 1 3 and 5 OR on days 1 3 5 7 9 and 11 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR or unconfirmed CR CRu receive 2 additional courses beyond CR or CRu for a maximum of 6 courses
Cohorts of 3-6 patients receive escalating doses of BL22 immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined the cohort is expanded and a total of 12 patients are treated at that dose
Patients are followed weekly for at least 1 month and then every 1-3 months thereafter
PROJECTED ACCRUAL A total of 95 patients will be accrued for this study
Primary
Determine the toxic effects of BL22 immunotoxin in pediatric patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia or non-Hodgkins lymphoma
Determine the maximum tolerated dose of this drug in these patients
Determine the immunogenicity of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Secondary
Determine the in vitro cytotoxicity of this drug against lymphoblasts from patients with acute lymphoblastic leukemia
Determine the therapeutic efficacy of this drug in inducing remissions in these patients
Determine changes in lymphocyte subsets immunoglobulin levels serum cytokines and soluble cytokine receptor levels in patients treated with this drug
OUTLINE This is a non-randomized dose-escalation study
Patients receive BL22 immunotoxin IV over 30 minutes on days 1 3 and 5 OR on days 1 3 5 7 9 and 11 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR or unconfirmed CR CRu receive 2 additional courses beyond CR or CRu for a maximum of 6 courses
Cohorts of 3-6 patients receive escalating doses of BL22 immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined the cohort is expanded and a total of 12 patients are treated at that dose
Patients are followed weekly for at least 1 month and then every 1-3 months thereafter
PROJECTED ACCRUAL A total of 95 patients will be accrued for this study
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-5643 | None | None | None |
| NCI-04-C-0079H | None | None | None |