Actively Recruiting
Phase IIa Study to Assess Safety and Efficacy in the Relapsed/Refractory Acute Myeloid Leukemia
Led by Changzhou Qianhong Bio-pharma Co., Ltd. · Updated on 2024-08-01
53
Participants Needed
10
Research Sites
91 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase IIa Study to Assess Safety and Efficacy in the Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign informed consent
- Age 18 and above
- Confirmed relapsed/refractory acute myeloid leukemia (R/R-AML) according to International Consensus Classification
- ECOG performance status of 2 points or less
- Expected survival of 3 months or more
- White blood cell count less than 25 x10^9 cells/L (hydroxyurea allowed to control count before treatment)
- Adequate liver function: total bilirubin ≤1.5 times upper limit of normal; ALT and AST ≤2.5 times upper limit of normal
- Adequate renal function: creatinine clearance ≥50 mL/min (Cockroft-Gault formula)
- Recovery from previous treatment toxicities to less than grade 2 (excluding primary disease effects and certain stable conditions)
- Specified washout periods from prior antitumor therapies before starting study treatment
- Ability to understand and complete visits, treatments, laboratory tests, and research procedures
- Use of effective contraception from consent signing until six months after last trial medication for subjects with reproductive potential; males must also refrain from sperm donation during this time
You will not qualify if you...
- Previous treatment with other CDK9 inhibitors
- Allergy to active ingredients or excipients of QHRD107, Venclexta, or azacitidine
- History of myeloproliferative tumors (MPN)
- History of chronic myeloid leukemia (CML)
- Presence of Philadelphia chromosome-positive or BCR-ABL fusion gene positive AML
- Confirmed acute promyelocytic leukemia
- AML with central nervous system infiltration
- Extramedullary leukemia except for lesions in liver, spleen, or lymph nodes
- Positive for HIV antibodies or active hepatitis B or C infection
- Active infections requiring systemic antibiotic treatment
- Significant active cardiovascular disease within past 6 months including severe heart failure, unstable angina, uncontrolled hypertension, uncontrolled arrhythmias, or reduced left ventricular function
- Allogeneic stem cell transplant within 60 days before study treatment without stopping immunosuppressants
- Previous CAR-T therapy
- Conditions preventing swallowing capsules or enteral drug administration
- History of other cancers within past 5 years except certain localized skin or cervical cancers
- Pregnant or breastfeeding women or those unwilling to use effective contraception
- Uncontrolled clinical problems or other factors preventing study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
2
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Actively Recruiting
3
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China, 213000
Actively Recruiting
4
Huai 'an First People's Hospital
Huaian, Jiangsu, China, 223300
Actively Recruiting
5
Zhongda Hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
6
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210036
Actively Recruiting
7
ShengJing Hospital
Shenyang, Liaoning, China, 110004
Actively Recruiting
8
Qilu Hospital of Shandong University
Jinan, Shangdong, China, 250000
Actively Recruiting
9
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
10
Ruijin hospitol
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
L
Li Junmin, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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