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

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

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

Sponsors & Collaborators

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• Jilin University

  collaborator OTHER

• The First Hospital of Jilin University

  lead OTHER

Principal Investigators

• Su J Gao, PhD · The First Hospital of Jilin University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2023-12-31

Completion

2024-10-31

Countries

• China

Study Locations