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

NCT ID: NCT03873311

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2023-06-01

Brief 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.

Conditions

Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azacytidine + HAG Regimen

Azacytidine（75mg/m2 ）+ HAG Regimen（Homoharringtonine(HHT) 1mg/(m2.d) , Cytarabine 10mg/(m2.d), G-CSF 200ug/(m2.d) )

Group Type: EXPERIMENTAL

Azacytidine, HAG Regimen

Intervention Type: DRUG

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

75mg/m2

Group Type: ACTIVE_COMPARATOR

Azacytidine

Intervention Type: DRUG

Azacytidine 75mg/m2 QD for 7 days.

Interventions

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)

Intervention Type: DRUG

Azacytidine

Azacytidine 75mg/m2 QD for 7 days.

Intervention Type: DRUG

Other Intervention Names

Azacytidine, HAG Regimen (HHT Cytarabine G-CSF)

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Xin Du, Phd

Role: primary

duxingz@medmail.com.cn

075583366388 ext. 8196

Other Identifiers

20190109

Identifier Type: -

Identifier Source: org_study_id