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

AML Clinical Trial

Official title:
Azacitidine in Combination With or Without All-trans Retinoic Acid in Newly Diagnosed Unfit Acute Myeloid Leukemia or Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria

Clinical Trial 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

Clinical Trial Description

Newly diagnosed unfit AML and Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria are unable to tolerate the intensive chemo-therapy regimens due to their old age and poor physical condition, resulting in limited overall survival. Nowadays, AZA are recommended for unfit acute myeloid leukemia or myelodysplastic syndromes patients with remission rate of 30%~34%. AZA with or without all-trans retinoic acid (ATRA) can cooperatively inhibit leukemia cell proliferation , induce apoptosis and differentiation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05175508
Study type Interventional
Source The First Affiliated Hospital of Soochow University
Contact Han Yue, Ph.D
Phone (0086)51267781856
Email hanyue@suda.edu.cn
Status Recruiting
Phase Phase 2/Phase 3
Start date May 1, 2021
Completion date May 1, 2023
View Details
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