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

Sponsor

The First Hospital of Jilin University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03026842

Collaborator

The Second Affiliated Hospital of Dalian Medical University (Other), Second Hospital of Jilin University (Other), Jilin University (Other)

180

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: Decitabine Drug: Daunorubicin, Cytarabine Drug: Mitoxantrone, Cytarabine Drug: Aclacinomycin, Cytarabine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Decitabine Six cycles of decitabine IV over one hour at 20 mg/m2/day for 5 days, every 6 weeks	Drug: Decitabine 20 mg/m2/day for 5 days
Active Comparator: Conventional chemotherapy Four cycles of conventional chemotherapy for 5 days, every 12 weeks. conventional chemotherapy includes in: DA regimen: Daunorubicin 45 mg/m2/day for 3 days, cytarabine 100 mg/m2/day for 5 days; MA regimen: Mitoxantrone 8 mg/m2/day for 3 days, cytarabine 100 mg/m2/day for 5 days; AA regimen: Aclacinomycin 20 mg/day for 5 days, cytarabine 100 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

Arm

Intervention/Treatment

Experimental: Decitabine

Six cycles of decitabine IV over one hour at 20 mg/m2/day for 5 days, every 6 weeks

Drug: Decitabine

20 mg/m2/day for 5 days

Active Comparator: Conventional chemotherapy

Four cycles of conventional chemotherapy for 5 days, every 12 weeks. conventional chemotherapy includes in: DA regimen: Daunorubicin 45 mg/m2/day for 3 days, cytarabine 100 mg/m2/day for 5 days; MA regimen: Mitoxantrone 8 mg/m2/day for 3 days, cytarabine 100 mg/m2/day for 5 days; AA regimen: Aclacinomycin 20 mg/day for 5 days, cytarabine 100 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

Outcome Measures

Primary Outcome Measures

Relapse free survival [Three years]

Secondary Outcome Measures

Overall survival [Three years]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [From enrolling to two months after administrating the last course of decitabine or chemotherapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients are adults age ≥18 and ≤60 years
Patients are diagnosed as AML with t(8;21)
Continuous complete remission after induction and consolidation therapy with 3 - 4 course high dose cytarabine (2 g/m^2)
Patients whose aspartate transaminase (AST)/alanine transaminase (ALT) are ≤ 2.5 times higher than the normal upper limit, total bilirubin ≤ 3.0 mg/dl, and serum creatinine ≤ 2.0 mg/dl.
Subjects that signed the informed consent, which indicated they understood the purpose, the procedure and potential benefits of the trial and were willing to participate in the trial.

Exclusion Criteria:

Pregnant or lactating women.
ECOG performance status score > 2.
Patients are candidates for hematopoietic stem cell transplantation.
Patients with a history of use of azacitidine or decitabine.
Patients with mental or other disorders that cannot completely cooperate with the treatment or follow up.
Subjects that were allergic to decitabine vehicle.
Patients receive immunotherapy.
Patients also have other organ malignant tumor.
Participating in other clinical research in the same period.
The researchers estimate that patients cannot enter the clinical trial.