NCT03978364

A Study of Azacitidine for Patients With Int/High -Risk MDS and AML-MRC

An Randomized Controlled Study of Azacitidine Combined With Homoharringtonine Compared With Azacitidine for Patients With Int/High -Risk MDS and AML-MRC

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shandong Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

evaluate the clinical efficacy and safety of azacitidine combined with HAG regimen for patients with int/high -risk MDS and AML-MRC with less than 30% blasts compared with azacitidine

Detailed description

Myelodysplastic syndromes (MDS) is a group of heterogeneous clonal diseases originating from hematopoietic stem cells. The most common types of acute myeloid leukemia (AML) are AML with myelodysplasia-related changes (AML-MRC) and AML-NOS. AML-MRC patients are usually with multilineage pathological hematopoiesis, previous history of MDS or MDS-related cytogenetic abnormalities. Compared with AML-NOS, AML-MRC patients are usually older, with poor prognosis of cytogenetic changes, low remission rate of chemotherapy, and worse overall prognosis. The treatment strategies mainly include demethylation drugs, chemotherapy and allogeneic hematopoietic stem cell transplantation. The main purpose of treatment is to delay disease progression, prolong survival, and even be cured. Epigenetic changes such as DNA methylation and histone deacetylation have been considered to be involved in the occurrence and development of MDS. Demethylation drugs, such as 5-azacitidine (AZA) and 5-aza-2-deoxycytidine (decitabine), can inhibit DNA methyltransferase, reduce excessive methylation of tumor suppressor genes, promote cell differentiation and apoptosis, and play an anti-tumor role. Demethylation drugs are important therapy for MDS patients. Compared with supportive treatment, demethylation drugs can reduce the risk of AML progression and improve survival. Therefore, we proposed this project in order to further clarify the role of azacytidine in therapy for high-risk and middle-risk MDS and AML-MRC patients, and evaluate its clinical efficacy, to explore the optimal azacytidine treatment strategies for high-risk and middle-risk MDS and AML-MRC patients.

Conditions

• Myelodysplastic Syndromes,Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Azacitidine combined HHT	Azacitidine 75mg/m2，iH，qd×7days，HHT，3mg/m2 ivdrip qd×3 days
DRUG	Azacitidine regimen	Azacitidine 75mg/m2，iH，qd×7days，28 days a cycle

Timeline

• Start date: 2019-06-01
• Primary completion: 2022-06-01
• Completion: 2022-12-31
• First posted: 2019-06-07
• Last updated: 2019-06-07

Locations

1 site across 1 country: China