ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies (NCT06656494)

🧪 Interventions in This Study

• ICP-248 (DRUG)
• Azacitidine (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Eligible subjects must meet all of the following criteria:
2. Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia \[APL\]) or MDS per 2016 World Health Organization (WHO) criteria.
3. For AML (except for APL) cohort:
4. Previously treated relapsed/refractory AML subjects
5. Treatment-naïve AML subjects should be: ≥60 years of age OR ≥18 years and \<60 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy
6. For MDS cohort: Adult TN MDS and R/R MDS: revised International Prognostic Scoring System (IPSS-R) score \> 3 and bone marrow blasts ≥ 5%.
7. Subject must have a projected life expectancy of at least 12 weeks.
8. Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.
9. Subject must have adequate liver function

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (22 Sites)

• Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange, California
• Yale University, Yale Cancer Center — New Haven, Connecticut
• H Lee Moffitt Cancer Center & Research Institute — Tampa, Florida
• NYU Langone Health — New York, New York
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
• Medical College of Wisconsin — Milwaukee, Wisconsin
• St Vincent's Hospital — Sydney, New South Wales
• Royal Perth Hospital — Perth, Western Australia
• Anhui Provincial Hospita — Hefei, Anhui
• Peking University People's Hospital — Beijing, Beijing Municipality
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong
• Nanfang Hospital Southern Medical University — Guangzhou, Guangdong
• Henan Cancer Hospital — Zhengzhou, Henan
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi
• The First Hospital of Jilin University — Changchun, Jilin
• Shengjing Hospital of China Medical University — Shengyang, Liaoning
• Sichuan Provincial People's Hospital — Chengdu, Sichuan
• Tianjin People's Hospital — Tianjin, Tianjin Municipality
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang

📞 Contact the Study Coordinator

Phone: 010-66609745

Email: CO_HGRAC@innocarepharma.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Acute Myelogenous Leukemia

• Allo HSCT Using RIC and PTCy for Hematological Diseases — Minneapolis, Minnesota
• Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia — Los Angeles, California
• ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis — Cleveland, Ohio
• Cord Blood Transplantation in Children and Young Adults With Blood Cancer — New York, New York
• The Prospective Collection, Storage and Reporting of Data on Patients Undergoing Hematopoietic Stem Cell Transplantation Utilizing a Standard Preparative Regimen — Winston-Salem, North Carolina

Explore by condition: All Acute Myelogenous Leukemia clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.