Ignite Creation Date:
2024-05-06 @ 4:20 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04953780
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2021-06-15
Brief Title:
2157GCCCPhase 1 of Calaspargase Pegol-mknl w Cytarabine and Idarubicin in Newly Dx AML
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
2157GCCC A Phase I Trial of Calaspargase Pegol-mknl in Combination With High Dose Cytarabine and Idarubicin in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Characterizing the regimen limiting toxicity RLT of chemotherapeutic drug Calaspargase Pegol-mknl as remission induction and consolidation chemotherapy in patients with newly diagnosed Acute Myeloid Leukemia AML and Identifying the Maximum Tolerated Dose MTD and Recommended Phase 2 Dose RP2D of Calaspargase Pegol-mknl
Detailed Description:
This is a single center non-randomized open-label phase I study evaluating regimen-limiting toxicities of Calaspargase Pegol-mknl administered intravenously in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia AML
The trial will consist of the induction and consolidation phases of therapy At the induction phase it usually lasts for 29 days a high-dose of Cytarabine will be administered IV for six doses plus Idarubicin administered IV for three doses and Calaspargase Pegol-mknl administered IV one dose using a dose-escalation scheme At the consolidation phase single cycle of consolidation lasts 4-8 weeks a high-dose of Cytarabine will be administered IV for six doses and Calaspargase Pegol-mknl administered IV for one dose using a dose-escalation scheme
The FDA The US Food and Drug Administration has not approved Calaspargase Pegol-mknl for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia AML
The trial will consist of the induction and consolidation phases of therapy At the induction phase it usually lasts for 29 days a high-dose of Cytarabine will be administered IV for six doses plus Idarubicin administered IV for three doses and Calaspargase Pegol-mknl administered IV one dose using a dose-escalation scheme At the consolidation phase single cycle of consolidation lasts 4-8 weeks a high-dose of Cytarabine will be administered IV for six doses and Calaspargase Pegol-mknl administered IV for one dose using a dose-escalation scheme
The FDA The US Food and Drug Administration has not approved Calaspargase Pegol-mknl for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia AML
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None