Ignite Creation Date:
2024-05-06 @ 3:23 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02283190
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2014-10-17
Brief Title:
1336GCC Study of Erwinaze for Treatment of Acute Myeloid Leukemia AML
Sponsor:
Ashkan Emadi
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
1336GCC Open-Label Single-Arm PK Study of IV Erwinaze Asparaginase Erwinia Chrysanthemi to Find the Dose With Acceptable Therapeutic and Safety Profile in Adults With Acute Myeloid Leukemia With or Without Isocitrate Dehydrogenase Mutations
Status:
COMPLETED
Status Verified Date:
2018-02
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:
Erwinaze will be administered intravenously at a dose of 25000 IUm2 dose cohort 0 for 6 doses MWF over a period of 2 weeks to 9 patients as described below and in the following schema Blood counts chemistries including bilirubin amylase and lipase and coagulation studies including fibrinogen will be measured and reviewed before each asparaginase dose Fibrinogen 100 mgdL can be replaced with cryoprecipitate before each dose at the discretion of treating physician Treatment will be stopped for elevation of amylase lipase or direct bilirubin above normal range
Detailed Description:
For safety
Erwinaze has been already used in clinical practice for treatment of patients with acute leukemia with known side effect profile For this reason in this protocol we use the 333 design for evaluation of safety based on pre-determined dose-limiting toxicities DLT In the 333 design the dose escalation rules proceed by adjusting the dose in cohorts of 3 to 9 patients per three dose levels20000 IUm2 dose cohort -1 25000 IUm2 dose cohort 0 30000 IUm2 dose cohort 1 The goal is to determine the Recommended Phase 2 Dose RP2D
For anti-leukemic activity
To evaluate the activity of Erwinaze to reduce the serum glutamine to the desired level the dose will be adjusted according to a pre-defined algorithm based on 48-hour trough serum glutamine level biochemical response prior to dose 6 of each patient If the safety profile is acceptable we will enroll up to a total of 15 patients at that dose level to better study and analyze the glutamine-reducing effect of Erwinaze at the defined dose
In summary if 9 patients are treated at a certain dose and at least 7 out of 9 individuals respond to treatment per serum glutamine levels and 3 develop DLT this dose level will be declared the Recommended Phase 2 Dose RP2D Six additional patients total of 15 to 18 patients will be enrolled at the RP2D level to better assess toxicity and to document responses
There will be no intra-patient dose escalation or reduction
Erwinaze has been already used in clinical practice for treatment of patients with acute leukemia with known side effect profile For this reason in this protocol we use the 333 design for evaluation of safety based on pre-determined dose-limiting toxicities DLT In the 333 design the dose escalation rules proceed by adjusting the dose in cohorts of 3 to 9 patients per three dose levels20000 IUm2 dose cohort -1 25000 IUm2 dose cohort 0 30000 IUm2 dose cohort 1 The goal is to determine the Recommended Phase 2 Dose RP2D
For anti-leukemic activity
To evaluate the activity of Erwinaze to reduce the serum glutamine to the desired level the dose will be adjusted according to a pre-defined algorithm based on 48-hour trough serum glutamine level biochemical response prior to dose 6 of each patient If the safety profile is acceptable we will enroll up to a total of 15 patients at that dose level to better study and analyze the glutamine-reducing effect of Erwinaze at the defined dose
In summary if 9 patients are treated at a certain dose and at least 7 out of 9 individuals respond to treatment per serum glutamine levels and 3 develop DLT this dose level will be declared the Recommended Phase 2 Dose RP2D Six additional patients total of 15 to 18 patients will be enrolled at the RP2D level to better assess toxicity and to document responses
There will be no intra-patient dose escalation or reduction
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