NCT03026842

Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Acute Myeloid Leukemia With t(8;21)

A Prospective, Randomized, Controlled Trial of Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Patients With Acute Myeloid Leukemia With t(8;21)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Acute myeloid leukemia (AML) is the most common hematological malignancies in adult patients with leukemia, and t(8;21) AML accounts for a substantial proportion of AML. AML patients with t(8;21) possess a favorable outcome and 3 - 4 course high dose cytarabine (3 g/m2) is the standard consolidation therapy for these patients with a 5-year overall survival approximately 60%. In China, intermediate dose cytarabine (1 - 2 g/m2) is used for consolidation therapy due to toxicities. After 3 - 4 course cytarabine consolidation, maintenance therapy is performed with conventional chemotherapy with a 5-year overall survival approximately 60% as well. However, continuous chemotherapy may cause toxicities and inhibit patients' immune response. Exploring new drug for maintenance therapy is urgently needed. Decitabine has a potent ability to inhibit proliferation and induce apoptosis of AML1-ETO positive leukemia cell line. Furthermore, the immunomodulatory effect of decitabine was also reported by several studies. In this study, the investigators plan to carry out a prospective, multicenter, randomized, controlled trail to compare decitabine versus conventional chemotherapy for maintenance therapy of patients with AML with t(8;21). Results of this trial may optimize the treatment for AML patients with t(8;21) in the setting of intermediate dose cytarabine consolidation.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Decitabine	20 mg/m2/day for 5 days
DRUG	Daunorubicin, Cytarabine	Daunorubicin: 45 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
DRUG	Mitoxantrone, Cytarabine	Mitoxantrone: 8 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
DRUG	Aclacinomycin, Cytarabine	Aclacinomycin: 20 mg/day for 5 days; Cytarabine: 100 mg/m2/day for 5 days

Timeline

• Start date: 2017-01-01
• Primary completion: 2023-12-01
• Completion: 2024-10-01
• First posted: 2017-01-20
• Last updated: 2017-01-20

Locations

1 site across 1 country: China