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

NCT03873311 | Unknown Phase 4

• 1 other identifier: 20190109
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Keywords

Azacytidine; HAG regimen

Outcome Measures

Primary Outcomes (1)

• Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments.

  4 months

Study Arms (2)

Azacytidine + HAG Regimen

EXPERIMENTAL

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

Drug: Azacytidine, HAG Regimen

Azacytidine

ACTIVE COMPARATOR

75mg/m2

Drug: Azacytidine

Interventions

Azacytidine, HAG Regimen 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)

Also known as: Azacytidine, HAG Regimen (HHT Cytarabine G-CSF)

Azacytidine + HAG Regimen

Azacytidine DRUG

Azacytidine 75mg/m2 QD for 7 days.

Azacytidine

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518035, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 13, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)