A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia

PHASE3RecruitingINTERVENTIONAL
Enrollment

316

Participants

Timeline

Start Date

April 26, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

September 30, 2029

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

HMPL-306 Regimen

Patients will receive HMPL-306 monotherapy: HMPL-306 PO at 250 mg QD (C1) + 150 mg QD (starting from C2), 28 days as a cycle.

DRUG

Salvage Chemotherapy Regimen

"Patients in this regimen will receive treatment with one of the following regimens, and the regimen will be selected by the investigator based on the patient's condition:~* EA±Mitox regimen: etoposide injection 100 mg/m2, cytarabine injection 100-150 mg/m2, mitoxantrone injection 8 mg/m2 QD IV for 5 consecutive days (Days 1-5).~* FLAG ± Ida regimen: G-CSF injection 300 mcg/m2 QD SC for 5 consecutive days (Days 1-5); fludarabine injection 30 mg/m2 QD IV for 5 consecutive days (Days 2-6); cytarabine injection 1000-2000 mg/m2 QD IV for 5 consecutive days (Days 2-6); idarubicin injection 10 mg/m2 QD IV for 3 consecutive days (Days 2-4).~* LoDAC: -Cytarabine Injection 20 mg every 12 hours, subcutaneous or IV for 10 consecutive days (Days 1-10).~* Azacitidine: Azacitidine Injection 75 mg/m2, QD, subcutaneous or IV for 7 consecutive days (Days 1-7)."

Trial Locations (53)

100044

RECRUITING

Peking University People's Hospital, Beijing

110001

RECRUITING

The First Hospital of China Medical University, Shenyang

110004

RECRUITING

Shengjing Hospital of China Medical University, Shenyang

130021

RECRUITING

The First Hospital of Jilin University, Changchun

150010

RECRUITING

Harbin First Hospital, Harbin

200025

RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

200065

RECRUITING

Tongji Hospital of Tongji University, Shanghai

210008

RECRUITING

Nanjing Drum Tower Hospital, Nanjing

210029

RECRUITING

Jiangsu Province Hospital, Nanjing

214023

RECRUITING

Wuxi People's Hospital, Wuxi

215006

RECRUITING

The First Affiliated Hospital of Soochow University, Suzhou

221004

RECRUITING

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

230001

RECRUITING

Anhui Provincial Hospital(The First Affiliated Hospital of U STC), Hefei

230022

RECRUITING

The First Affiliated Hospital of Anhui Medical University, Hefei

230601

RECRUITING

The Second Hospital of Anhui Medical University, Hefei

250012

RECRUITING

Qilu Hospital of Shandong University, Jinan

300020

RECRUITING

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin

300121

RECRUITING

Tianjin People's Hospital, Tianjin

310003

RECRUITING

The First Affiliated Hospital, Zhejiang University, Hangzhou

325000

RECRUITING

The First Affiliated Hospital of WMU, Wenzhou

330006

RECRUITING

The First Affiliated Hospital of Nanchang University, Nanchang

350001

RECRUITING

Fujian Medical University Union Hospital, Fuzhou

350005

RECRUITING

The First Affilated Hospital of Fujian Medical University, Fuzhou

361003

RECRUITING

The First Affiliated Hospital of Xiamen University, Xiamen

362000

RECRUITING

Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou

400016

RECRUITING

The First Affiliated Hospital of Chongqing Medical University, Chongqing

410005

RECRUITING

People's Hospital of Hunan Province, Changsha

410008

RECRUITING

Xiangya Hospital Central South University, Changsha

410013

RECRUITING

The Third Xiangya Hospital of Central South University, Changsha

430022

RECRUITING

Wuhan Union Hospital of China, Wuhan

430071

RECRUITING

Zhongnan Hospital of Wuhan University, Wuhan

450008

RECRUITING

The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou

450052

RECRUITING

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

471003

RECRUITING

The First Affilated Hospital of Henan University of Science & Technology, Luoyang

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

510180

RECRUITING

Guangzhou First People's Hospital, Guangzhou

510515

RECRUITING

Nanfang Hospital,Southern Medical University, Guanzhou

518035

RECRUITING

Shenzhen Second People's Hospital, Shenzhen

524001

RECRUITING

Affiliated Hospital of Guangdong Medical University, Zhanjiang

530021

RECRUITING

The First Affiliated Hospital of Guangxi Medical University, Nanning

550002

RECRUITING

Guizhou Provincial People's Hospital, Guiyang

550004

RECRUITING

The Affiliated Hospital of Guizhou Medical University, Guiyang

563003

RECRUITING

Affiliated Hospital of Zunyi Medical Univercity, Zunyi

610041

RECRUITING

West China Hospital of Sichuan University, Chengdu

610072

RECRUITING

Sichuan Provincial People's Hospital, Chengdu

644000

RECRUITING

The second people's hospital of Yibin, Yibin

650032

RECRUITING

The First Affiliated Hospital of Kunming Medical University, Kunming

RECRUITING

The First People's Hospital of Yunnan Province, Kunming

710004

RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hosiptal), Xi'an

830001

RECRUITING

XinjiangUiger Municipal People's Hospital, Ürümqi

071000

RECRUITING

Baoding NO.1 Central Hospital, Baoding

067000

RECRUITING

Affiliated Hospital of Chengde Medical University, Chengde

050000

RECRUITING

The Second Hospital of Hebei Medical University, Shijiazhuang

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Hutchmed

INDUSTRY