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NCT05581030 · ClinicalTrials.gov registry record · Phase 1

CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

A Phase 1 study of Acute Lymphoblastic Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Recruiting
Registry status
Phase 1
Development phase
7
Enrollment target
1
Study location

NCT05581030: Recruiting Phase 1 study of Acute Lymphoblastic Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT05581030 is a Phase 1 study of Acute Lymphoblastic Leukemia that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 7 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05581030, a Phase 1 study of Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

RECRUITING
Registry status
Phase 1
Development phase
7 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.

Primary Outcome

Mortality rate is hypothesized to be less than 10% when combining calaspargase pegol with Hyper-CVAD.

Interventions

  • DRUG Rituximab
  • DRUG Calaspargase Pegol
  • DRUG Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy)

Study Locations (1)

Florida

  • Moffitt Cancer Center - Tampa

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2023-05-01
Est. Completion 2026-10
Phase Phase 1

What NCT05581030 shows while recruiting

NCT05581030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.

NCT05581030 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT05581030 about?

NCT05581030 is a clinical study titled "CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)". The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.

What is the current status of trial NCT05581030?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2023-05-01. Estimated completion is 2026-10.

What conditions does trial NCT05581030 study?

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

What interventions are being tested in trial NCT05581030?

The interventions under investigation include: Rituximab (DRUG), Calaspargase Pegol (DRUG), Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy) (DRUG).

Who is sponsoring clinical trial NCT05581030?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05581030 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Acute Lymphoblastic 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 NCT05581030's enrollment target sits among peer trials

7 126th of 131 higher than 1 of 131 other Acute Lymphoblastic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Lymphoblastic 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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Source: ClinicalTrials.gov NCT05581030, the US trial registry maintained by the National Library of Medicine. NCT05581030 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.