Aza With or Without ATRA in Newly Diagnosed Unfit AML or Intermediate,High or Very High Risk MDS

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open-label, multicenter study to compare the efficacy and safety of AZA with or without ATRA in newly diagnosed unfit AML or Intermediate,High or Very High Risk MDS

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Treatments: Azacitidine; Tretinoin

Criteria

Inclusion Criteria:

• Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (2017 edition)，excludes acute promyelocytic leukemia (M3、APL) and myelodysplastic syndromes(2017 edition)

• Be at least 18 years of age on day of signing informed consent

• Not suitable for newly diagnosed patients with intensive chemotherapy

• Not suitable for newly diagnosed patients with receiving hematopoietic stem cell transplantation

• The proportion of blast cells was below 50% in bone marrow

• Total white blood cell (WBC) count ≤10,000/µL；Must be able to swallow tablets

Exclusion Criteria:

• Malignant neoplasms with other progression

• Serious mental illness uncooperative

• Refusal to join the study