Azacytidine + HAG Regimen vs. Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy

Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia Clinical Trial

Official title:

The Efficacy and Safety of Azacytidine Combined With HAG Regimen Versus Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy: a Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03873311
• Other study ID #: 20190109
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2022
• Source: Shenzhen Second People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to explore the efficacy and safety of azacytidine and HAG regimen versus azacytidine for elderly patients with Newly Diagnosed MDS/AML/CMML in China. This is a post-marketing, interventional, multi-center, double-arm, prospective, open-label, randomized controlled study in elderly patients with MDS/AML/CMML in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given azacytidine + HAG regimen or azacytidine under the conditions of informed consent and frequent monitoring according to the clinical guideline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: June 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age = 60;
• Patients with newly diagnoised diseases including MDS/AML/CMML;
• The ECOG behavior status score is less than 3 points;
• Agree to sign informed consent

Exclusion Criteria:

• Patients with a history of sever heart disease;
• Patients with severe organ dysfunction;
• Patients with other malignancies
• Patients who are allergic to the treatment of drug ingredients

Related Conditions & MeSH terms

• Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile
• Myelodysplastic Syndromes

Intervention

Drug:
• Azacytidine, HAG Regimen
Azacytidine(75mg/m2 QD for 7 days)+ HAG Regimen(Homoharringtonine(HHT) 1mg/(m2.d) for 14 days), Cytarabine 10mg/(m2.d) for 14 days, granulocyte colony-stimulating factor(G-CSF) 200ug/(m2.d) for 14 days until absolute neutrophil count(ANC) = 10X109/L)
• Azacytidine
Azacytidine 75mg/m2 QD for 7 days.

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments.		4 months