Clinical Trial

2157GCCC:Phase 1 of Calaspargase Pegol-mknl W/ Cytarabine and Idarubicin in Newly Dx AML

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated March 6, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-06-28; most recent amendment 2025-03-03.
Status change: Recruiting → Active, Not Recruiting 2024-03-14
Status change: Not Yet Recruiting → Recruiting 2021-12-14
Trial Details
NCT Number NCT04953780
Lead Sponsor West Virginia University
Conditions Acute Myeloid Leukemia
Enrollment 6 participants
Start Date 2021-09-27
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-06