RecruitingPhase 2NCT06532058

Phase IIa Study to Assess Safety and Efficacy in the Relapsed/Refractory Acute Myeloid Leukemia

Safety and Efficacy of QHRD107 Capsule Combined With Venclexta and Azacitidine in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia: a Single-arm, Open, Multicenter Phase IIa Study


Sponsor

Changzhou Qianhong Bio-pharma Co., Ltd.

Enrollment

53 participants

Start Date

Aug 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the safety and efficacy of QHRD107 capsule combined with Venclexta and azacitidine in the treatment of relapsed/refractory acute myeloid leukemia: a single-arm, open, multicenter Phase IIa study


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2a study tests a new drug combination — QHRD107 (a CDK9 inhibitor), venetoclax, and azacitidine — in adults with relapsed or refractory acute myeloid leukemia (AML), a fast-moving blood cancer that has come back or stopped responding to previous treatments. Researchers want to see if this combination is safe and effective for these hard-to-treat patients. **You may be eligible if...** - You are 18 or older with AML that has relapsed (come back) or not responded to previous treatment - Your AML failed 2 or more standard treatment courses, came back within 12 months of remission, or has relapsed twice or more - You are in reasonably good health (ECOG score of 0-2) - Your liver and kidney function are adequate - Your white blood cell count is manageable **You may NOT be eligible if...** - You have previously received a CDK9 inhibitor - You have a history of certain blood cancers like CML or MPN, or a specific chromosome abnormality (Ph+ or BCR-ABL) - You have acute promyelocytic leukemia (APL) - You have HIV or active hepatitis B or C - You have had a recent allogeneic stem cell transplant (within 60 days) - You are pregnant or breastfeeding - You have significant active heart problems 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

DRUGQHRD107 capsule,Venclexta and Azacitidine

QHRD107(orally),Venclexta(orally),Azacitidine(subcutaneous injection)


Locations(10)

Henan Cancer Hospital

Zhengzhou, Henan, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Huai 'an First People's Hospital

Huaian, Jiangsu, China

Zhongda Hospital

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

ShengJing Hospital

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shangdong, China

Tongren Hospital Shanghai Jiao Tong University School Of Medicine

Shanghai, Shanghai Municipality, China

Ruijin hospitol

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06532058


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