Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017472
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2001-06-06
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia Lymphocytic Lymphoma Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Thrice Weekly Hu1D10in Patients With Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma and Acute Leukemia
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:
Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia lymphocytic lymphoma acute lymphoblastic leukemia or acute myeloid leukemia
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD or biological effective dose of monoclonal antibody Hu1D10 apolizumab in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma
II Determine the safety of this drug in terms of frequency and severity of treatment-related adverse events in this patient population
SECONDARY OBJECTIVES
I Determine whether this drug has anti-leukemialymphoma activity in patients expressing the Hu1D10 antigen
II Determine the pharmacokinetics of this drug in this patient population III Determine whether the infusion-related toxicity of this drug is secondary to cytokine release in these patients
IV Determine whether the intensity of 1D10 target antigen on tumor cells is related to clinical response and treatment toxicity in these patients
V Determine the pharmacodynamics of this drug in this patient population
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to diagnosis chronic lymphocytic leukemia or small lymphocytic lymphoma vs acute lymphoblastic leukemia ALL or acute myeloid leukemia AML Patients with ALL or AML are enrolled after the maximum tolerated dose MTD is determined
Patients receive apolizumab IV over at least 2 hours on days 1 2 3 5 8 10 12 15 17 19 22 24 and 26 Treatment continues in the absence of disease progression or unacceptable toxicity Patients with a complete or partial response who relapse after 2 months may receive an additional course of therapy provided they still express the 1D10 antigen
Cohorts of 3-6 patients receive escalating doses of MOAB Hu1D10 until the MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity DLT If no DLT is observed the biological effective dose BED is determined in the above cohorts The BED is defined as the dose at which at least 4 of 6 patients experience an acceptable minimum trough level and clinical response An additional 24 patients 12 per stratum are treated at the MTD
Patients are followed at 1 week 1 and 2 months and then every 3 months for 1 year
PROJECTED ACCRUAL A total of 35 patients 12 per stratum will be accrued for this study
I Determine the maximum tolerated dose MTD or biological effective dose of monoclonal antibody Hu1D10 apolizumab in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma
II Determine the safety of this drug in terms of frequency and severity of treatment-related adverse events in this patient population
SECONDARY OBJECTIVES
I Determine whether this drug has anti-leukemialymphoma activity in patients expressing the Hu1D10 antigen
II Determine the pharmacokinetics of this drug in this patient population III Determine whether the infusion-related toxicity of this drug is secondary to cytokine release in these patients
IV Determine whether the intensity of 1D10 target antigen on tumor cells is related to clinical response and treatment toxicity in these patients
V Determine the pharmacodynamics of this drug in this patient population
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to diagnosis chronic lymphocytic leukemia or small lymphocytic lymphoma vs acute lymphoblastic leukemia ALL or acute myeloid leukemia AML Patients with ALL or AML are enrolled after the maximum tolerated dose MTD is determined
Patients receive apolizumab IV over at least 2 hours on days 1 2 3 5 8 10 12 15 17 19 22 24 and 26 Treatment continues in the absence of disease progression or unacceptable toxicity Patients with a complete or partial response who relapse after 2 months may receive an additional course of therapy provided they still express the 1D10 antigen
Cohorts of 3-6 patients receive escalating doses of MOAB Hu1D10 until the MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity DLT If no DLT is observed the biological effective dose BED is determined in the above cohorts The BED is defined as the dose at which at least 4 of 6 patients experience an acceptable minimum trough level and clinical response An additional 24 patients 12 per stratum are treated at the MTD
Patients are followed at 1 week 1 and 2 months and then every 3 months for 1 year
PROJECTED ACCRUAL A total of 35 patients 12 per stratum 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 |
|---|---|---|---|
| OSU 0101 | None | None | None |
| OSU-0101 | None | None | None |
| NCI-1254 | None | None | None |
| OSU-00H0230 | None | None | None |
| CDR0000068695 | None | None | None |
| U01CA076576 | NIH | None | httpsreporternihgovquickSearchU01CA076576 |