Overview

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