RecruitingPhase 2NCT06453902

TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients

A Single-arm, Open-label, Multi-center Phase II Study Evaluating Efficacy and Safety of TGRX-678 in CML-AP Patients Relapsed or Refractory From 3rd-generation TKI Treatment


Sponsor

Shenzhen TargetRx Co., Ltd.

Enrollment

40 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Chinese Phase II study tests a new drug called TGRX-678 in patients with chronic myelogenous leukemia (CML) — a blood cancer — that has stopped responding to multiple prior targeted therapy drugs, including third-generation TKI treatments. **You may be eligible if...** - You are 18 or older with CML in the accelerated phase confirmed by bone marrow testing - Your leukemia has relapsed or is not responding to third-generation TKI therapy - You are in reasonably good health (ECOG score 2 or lower) - Your blood counts and organ function (liver, kidneys, heart) are adequate **You may NOT be eligible if...** - You received a TKI drug or still have side effects from one within the past 7 days - You are currently receiving other anti-tumor treatments - You are pregnant or not willing to use contraception during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTGRX-678

All patients will be given TGRX-678 240 mg once daily. TGRX-678 is to be taken orally


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06453902


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