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NCT04953780 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Acute Myeloid Leukemia, sponsored by West Virginia University.

Active
Registry status
Phase 1
Development phase
6
Enrollment target
2
Study locations

NCT04953780: Active Phase 1 study of Acute Myeloid Leukemia, sponsored by West Virginia University.

NCT04953780 is a Phase 1 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by West Virginia University. The registered enrollment target is 6 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04953780, a Phase 1 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by West Virginia University.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
6 participants
Enrollment target
2
Study locations

Study 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.

Primary Outcome

1\. Incidence of regimen limiting toxicities (RLTs) and Incidence of treatment-emergent adverse events (TEAE).

Conditions Studied

Acute Myeloid Leukemia

Interventions

  • DRUG Calaspargase pegol-mknl

Study Locations (2)

Maryland

  • Greenebaum Cancer Center, University of Maryland Medical Systems - Baltimore

West Virginia

  • West Virginia University - Morgantown

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2021-09-27
Est. Completion 2025-12-31
Phase Phase 1
West Virginia University

122 total trials

What the registry record for NCT04953780 still lists

NCT04953780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (95% lower).

The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Calaspargase pegol-mknl is the first listed.

NCT04953780 reports a single indexed study location in Maryland, West Virginia.

Frequently Asked Questions

What is clinical trial NCT04953780 about?

NCT04953780 is a clinical study titled "2157GCCC:Phase 1 of Calaspargase Pegol-mknl W/ Cytarabine and Idarubicin in Newly Dx AML". 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)...

What is the current status of trial NCT04953780?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-09-27. Estimated completion is 2025-12-31.

What conditions does trial NCT04953780 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia.

What interventions are being tested in trial NCT04953780?

The interventions under investigation include: Calaspargase pegol-mknl (DRUG).

Who is sponsoring clinical trial NCT04953780?

This trial is sponsored by West Virginia University, which has 122 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04953780 being conducted?

This trial has 2 study locations across Maryland, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04953780's enrollment target sits among peer trials

6 303rd of 306 higher than 3 of 306 other Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04953780, the US trial registry maintained by the National Library of Medicine. NCT04953780 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.