Aza With or Without ATRA in Newly Diagnosed Unfit AML or Intermediate,High or Very High Risk MDS
- Conditions
- MDSOld Age; DebilityHematologic CancerAML
- Interventions
- Registration Number
- NCT05175508
- Brief 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
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- 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
- Malignant neoplasms with other progression
- Serious mental illness uncooperative
- Refusal to join the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Azacytidine Combined With ARTA Azacitidine Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle with ATRA 20mg tid by po on days 1-21 of every cycle 28 days Azacytidine Azacitidine Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle Azacytidine Combined With ARTA all trans retinoic acid Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle with ATRA 20mg tid by po on days 1-21 of every cycle 28 days
- Primary Outcome Measures
Name Time Method Overall survival (OS) 24months time from randomization to death from any cause, or last known date to be alive.
Progression-free survival (PFS) 24 months Progression-free survival (PFS) will be measured from time of enrolling in the clinical trial to the date on which disease progresses or the date on which the patient dies, whichever comes first.
Overall Response Rate （ORR) 6 months Number of participants (responders) achieving ORR after the 6 cycle treatments，Overall response rate (ORR) based on the International Working Group (IWG)-2006 criteria, which include complete remission (CR), partial remission (PR), and major hematologic improvement (HI).
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline 6 months TI is when the participants who were transfusion dependent on RBC and/or Platelet at baseline achieve transfusion independence post baseline. TI is a period of at least 56 days with no transfusion after the date of the first dose of study drug to the last dose of study drug + 30 days, the initiation of post-treatment therapy, or death, whichever is earliest.
Incidence of systemic infections 6 months Incidence of systemic infections
Trial Locations
- Locations (1)
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China