Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666649
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2020-12-07
Brief Title:
Pegcrisantaspase in Combination With Venetoclax for Treatment of Relapsed or Refractory Acute Myeloid Leukemia RR AML
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Pegcrisantaspase in Combination With Venetoclax for Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
Evaluate the safety and tolerability of pegcrisantaspase in combination with venetoclax Ven-PegC and estimate the maximum tolerated doses andor biologically active doses of Ven-PegC in patients with relapsed or refractory acute myeloid leukemia RR AML
Detailed Description:
This research study is a non-randomized open-label Phase Ib clinical trial evaluating venetoclax Ven administered orally daily in combination with pegcrisantaspase PegC administered IV biweekly as part of a 28-day treatment cycle in adult subjects with relapsed or refractory acute myeloid leukemia RR AML
The trial will consist of dose escalation to evaluate the safety and tolerability of Ven-PegC and estimate the maximum tolerated doses MTDs andor biologically active doses eg recommended phase 2 doses RP2Ds of Ven-PegC in patients with RR AML
Venetoclax is an FDA the US Food and Drug Administration approved drug but this combination Ven-PegC has not been approved by the FDA
The trial will consist of dose escalation to evaluate the safety and tolerability of Ven-PegC and estimate the maximum tolerated doses MTDs andor biologically active doses eg recommended phase 2 doses RP2Ds of Ven-PegC in patients with RR AML
Venetoclax is an FDA the US Food and Drug Administration approved drug but this combination Ven-PegC has not been approved by the FDA
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