Actively Recruiting
A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia
Led by Hutchmed · Updated on 2025-08-14
316
Participants Needed
53
Research Sites
283 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, open-label, phase III clinical study (RAPHAEL) to evaluate the efficacy, safety, and PK of HMPL-306 versus salvage chemotherapy in patients with R/R AML harboring IDH1 and IDH2 mutations.
CONDITIONS
Official Title
A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Able to follow study protocol requirements
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- For Cohort 1: Patients with relapsed/refractory primary AML harboring IDH1-R132 mutation (excluding APL and extramedullary leukemia without bone marrow involvement)
- For Cohort 2: Patients with relapsed/refractory primary AML harboring IDH2-R140 or R172 mutations; patients with both mutations included in Cohort 2
- Agree to undergo bone marrow aspiration and/or biopsy before and during treatment
- Willing to complete quality of life assessments during and after treatment
- Female patients of childbearing potential must use effective contraception during the study and for 30 days after discontinuation (6 months for chemotherapy group), not donate eggs, not be lactating, and have a negative pregnancy test
- Male patients with female partners of childbearing potential must use condoms during intercourse and avoid donating or freezing sperm during the study and for 30 days after discontinuation (6 months for chemotherapy group)
- Predicted survival greater than 12 weeks as assessed by the investigator
You will not qualify if you...
- Prior treatment with IDH1, IDH2, or dual IDH1/IDH2 inhibitors
- Known current RAS or FLT3 hotspot mutations (unless previously tested negative at enrollment)
- Liver function abnormalities: total bilirubin over 1.5 times upper limit of normal (with exceptions), AST or ALT above specified limits
- Impaired kidney function: creatinine clearance under 50 mL/min or creatinine over 1.5 times upper limit
- Blood clotting abnormalities (INR or aPTT over 1.5 times upper limit) unless on anticoagulants
- Elevated blood amylase over 1.5 times upper limit with clinical significance
- Current liver disease including cirrhosis, alcoholic liver disease, active hepatitis B or C infection unless viral load is low or negative
- Known HIV infection
- Significant heart conditions requiring intervention or specific ECG abnormalities
- Other primary cancers within past 5 years except certain treated non-invasive tumors
- Pregnant or breastfeeding women
- Childbearing requirements unmet
- Recent stroke or intracranial hemorrhage within 6 months
- Major surgery within 4 weeks before randomization
- Recent use of monoclonal antibodies, investigational products, anti-tumor therapies, radiotherapy, CAR-T therapy, or hematopoietic stem cell transplantation within specified washout periods
- Active central nervous system leukemia
- Recent live vaccinations or use of traditional Chinese medicines with anti-tumor effects
- Uncontrolled active infections or persistent unexplained fever
- Inability to take oral medications or severe gastrointestinal diseases affecting drug absorption
- Poor compliance judged by investigator
- Unresolved toxicities from previous anti-tumor treatments above Grade 1 (excluding hair loss)
- Any other significant medical or laboratory abnormalities that may affect safety or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 53 locations
1
Anhui Provincial Hospital（The First Affiliated Hospital of U STC）
Hefei, Anhui, China, 230001
Actively Recruiting
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
3
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
4
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
5
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
6
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
7
The First Affilated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
8
Quanzhou First Hospital Affiliated to Fujian Medical University
Quanzhou, Fujian, China, 362000
Actively Recruiting
9
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
10
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
11
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
Actively Recruiting
12
Nanfang Hospital，Southern Medical University
Guanzhou, Guangdong, China, 510515
Actively Recruiting
13
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China, 518035
Actively Recruiting
14
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China, 524001
Actively Recruiting
15
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
16
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Actively Recruiting
17
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
Actively Recruiting
18
Affiliated Hospital of Zunyi Medical Univercity
Zunyi, Guizhou, China, 563003
Actively Recruiting
19
Baoding NO.1 Central Hospital
Baoding, Hebei, China, 071000
Actively Recruiting
20
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China, 067000
Actively Recruiting
21
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
22
Harbin First Hospital
Harbin, Heilongjiang, China, 150010
Actively Recruiting
23
The First Affilated Hospital of Henan University of Science & Technology
Luoyang, Henan, China, 471003
Actively Recruiting
24
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
25
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
26
Wuhan Union Hospital of China
Wuhan, Hubei, China, 430022
Actively Recruiting
27
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
28
People's Hospital of Hunan Province
Changsha, Hunan, China, 410005
Actively Recruiting
29
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
30
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Actively Recruiting
31
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
32
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
33
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
34
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214023
Actively Recruiting
35
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221004
Actively Recruiting
36
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
37
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
38
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
39
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
40
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hosiptal)
Xi'an, Shaanxi, China, 710004
Actively Recruiting
41
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
42
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
43
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China, 200065
Actively Recruiting
44
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
45
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
46
The second people's hospital of Yibin
Yibin, Sichuan, China, 644000
Actively Recruiting
47
XinjiangUiger Municipal People's Hospital
Ürümqi, Xinjiang, China, 830001
Actively Recruiting
48
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Actively Recruiting
49
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China, 650032
Actively Recruiting
50
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
51
The First Affiliated Hospital of WMU
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
52
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, China, 300020
Actively Recruiting
53
Tianjin People's Hospital
Tianjin, China, 300121
Actively Recruiting
Research Team
E
Erin Lou, Doctor
CONTACT
Y
Yu Wang, Bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here