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NCT05143840 · ClinicalTrials.gov registry record · Phase 2
Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase
A Phase 2 study of Leukemia, Myeloid and Leukemia, Myeloid, Chronic, sponsored by Augusta University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 7
- Study locations
NCT05143840: Recruiting Phase 2 study of Leukemia, Myeloid and Leukemia, Myeloid, Chronic, sponsored by Augusta University.
NCT05143840 is a Phase 2 study of Leukemia, Myeloid and Leukemia, Myeloid, Chronic that is actively recruiting participants, run by Augusta University. The registered enrollment target is 100 participants, below the 383-participant average among 8 other Leukemia, Myeloid trials with a reported enrollment target (74% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05143840, a Phase 2 study of Leukemia, Myeloid and Leukemia, Myeloid, Chronic, is actively recruiting participants, sponsored by Augusta University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. Patients will receive asciminib 80 mg orally once daily during the single asciminib phase. Response is determined by PCR (polymerase chain reaction) blood test during the study. Patients who have not achieved a response after 24 months (but no later than 36 months) of single agent asciminib will be offered the addition of a low dose tyrosine kinase inhibitor (low-TKI) namely dasatinib, imatinib, or nilotinib at the investigator's discretion. The following doses of the TKIs will be used: 1. Dasatinib 50 mg daily 2. Imatinib 300 mg daily 3. Nilotinib 300 mg daily Patients will discontinue study treatment if they experience disease progression, or unacceptable toxicity.
Primary Outcome
The proportion of patients achieving BCR::ABL1 \<0.01% IS (MR4.0) within 12 months of treatment with single agent asciminib
Conditions Studied
Interventions
- DRUG Single Agent Asciminib
- COMBINATION_PRODUCT Low TKI
- OTHER Elective Free Treatment
Study Locations (7)
Georgia
- Winship Cancer Institute Emory University - Atlanta
- Georgia Cancer Center at Augusta University - Augusta
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Memorial Sloan Kettering Cancer Center - New York
Michigan
- Karmanos Cancer Institute - Detroit
Utah
- Huntsman Cancer Institute - Salt Lake City
Wisconsin
- Froedtert Hospital & the Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-04-22 |
| Est. Completion | 2032-02 |
| Phase | Phase 2 |
What NCT05143840 shows while recruiting
NCT05143840 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 383-participant average among 8 other Leukemia, Myeloid trials with a reported enrollment target (74% lower).
The record links to 4 conditions, with Leukemia, Myeloid appearing as the primary indexed condition, and to 3 interventions - of which Single Agent Asciminib is the first listed.
NCT05143840 lists 7 locations in 5 states (Georgia, New York, Michigan).
Frequently Asked Questions
What is clinical trial NCT05143840 about?
NCT05143840 is a clinical study titled "Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase". This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. ...
What is the current status of trial NCT05143840?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2022-04-22. Estimated completion is 2032-02.
What conditions does trial NCT05143840 study?
This clinical trial studies the following conditions: Leukemia, Myeloid, Leukemia, Myeloid, Chronic, Chronic Myeloid Leukemia, Chronic Phase, Adult CML.
What interventions are being tested in trial NCT05143840?
The interventions under investigation include: Single Agent Asciminib (DRUG), Low TKI (COMBINATION_PRODUCT), Elective Free Treatment (OTHER).
Who is sponsoring clinical trial NCT05143840?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05143840 being conducted?
This trial has 7 study locations across Georgia, Michigan, New York, Utah, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05143840's enrollment target sits among peer trials
100 4th of 8 higher than 5 of 8 other Leukemia, Myeloid trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia, Myeloid 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.
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