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NCT04260022 · ClinicalTrials.gov registry record · Phase 1
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
A Phase 1 study of Chronic Myeloid Leukemia and Myeloid Leukemia, sponsored by Ascentage Pharma Group.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 242
- Enrollment target
- 9
- Study locations
NCT04260022: Recruiting Phase 1 study of Chronic Myeloid Leukemia and Myeloid Leukemia, sponsored by Ascentage Pharma Group.
NCT04260022 is a Phase 1 study of Chronic Myeloid Leukemia and Myeloid Leukemia that is actively recruiting participants, run by Ascentage Pharma Group. The registered enrollment target is 242 participants, above the 203-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (19% higher). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04260022, a Phase 1 study of Chronic Myeloid Leukemia and Myeloid Leukemia, is actively recruiting participants, sponsored by Ascentage Pharma Group.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 242 participants
- Enrollment target
- 9
- Study locations
Study Summary
A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI.
Primary Outcome
To evaluate the Maximum Plasma Concentration (Cmax) of HQP1351
Conditions Studied
Interventions
- DRUG Ascentage Pharma HQP1351 bioavailable inhibitor
- DRUG Blinatumomab
Study Locations (9)
Georgia
- Winship Cancer Institute, Emory University - Atlanta
- Augusta Cancer Center - Augusta
Alabama
- University of Alabama at Birmingham - Birmingham
California
- City of Hope - Duarte
Maryland
- University of Maryland - Baltimore
Ohio
- Cleveland Clinic - Cleveland
Texas
- University of Texas MD Anderson Cancer Center - Houston
Washington
- Fred Hutchinson Cancer Research Center - Seattle
Ontario
- Princess Margaret Cancer Centre - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2020-01-09 |
| Est. Completion | 2030-03-31 |
| Phase | Phase 1 |
What NCT04260022 shows while recruiting
NCT04260022 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, above the 203-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (19% higher).
The record links to 5 conditions, with Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Ascentage Pharma HQP1351 bioavailable inhibitor is the first listed.
NCT04260022 lists 9 locations in 8 states (Georgia, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT04260022 about?
NCT04260022 is a clinical study titled "Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL". A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistanc...
What is the current status of trial NCT04260022?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 242 participants. The study started on 2020-01-09. Estimated completion is 2030-03-31.
What conditions does trial NCT04260022 study?
This clinical trial studies the following conditions: Chronic Myeloid Leukemia, Myeloid Leukemia, Leukemia, Myeloid, Chronic, Philadelphia Positive Acute Lymphoblastic Leukemia, B Cell Precursor Type Acute Leukemia.
What interventions are being tested in trial NCT04260022?
The interventions under investigation include: Ascentage Pharma HQP1351 bioavailable inhibitor (DRUG), Blinatumomab (DRUG).
Who is sponsoring clinical trial NCT04260022?
This trial is sponsored by Ascentage Pharma Group, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04260022 being conducted?
This trial has 9 study locations across Alabama, California, Georgia, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Myeloid Leukemia
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Where NCT04260022's enrollment target sits among peer trials
242 7th of 35 higher than 29 of 35 other Chronic Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic 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.
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