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

NCT ID: NCT03026842

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2024-10-31

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Decitabine

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

Group Type: EXPERIMENTAL

Decitabine

Intervention Type: DRUG

20 mg/m2/day for 5 days

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.

Group Type: ACTIVE_COMPARATOR

Daunorubicin, Cytarabine

Intervention Type: DRUG

Daunorubicin: 45 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days

Mitoxantrone, Cytarabine

Intervention Type: DRUG

Mitoxantrone: 8 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days

Aclacinomycin, Cytarabine

Intervention Type: DRUG

Aclacinomycin: 20 mg/day for 5 days; Cytarabine: 100 mg/m2/day for 5 days

Interventions

Decitabine

20 mg/m2/day for 5 days

Intervention Type: DRUG

Daunorubicin, Cytarabine

Daunorubicin: 45 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days

Intervention Type: DRUG

Mitoxantrone, Cytarabine

Mitoxantrone: 8 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days

Intervention Type: DRUG

Aclacinomycin, Cytarabine

Aclacinomycin: 20 mg/day for 5 days; Cytarabine: 100 mg/m2/day for 5 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients are adults age ≥18 and ≤60 years

2. Patients are diagnosed as AML with t(8;21)

3. Continuous complete remission after induction and consolidation therapy with 3 - 4 course high dose cytarabine (2 g/m^2)

4. 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.

5. 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

1. Pregnant or lactating women.

2. ECOG performance status score > 2.

3. Patients are candidates for hematopoietic stem cell transplantation.

4. Patients with a history of use of azacitidine or decitabine.

5. Patients with mental or other disorders that cannot completely cooperate with the treatment or follow up.

6. Subjects that were allergic to decitabine vehicle.

7. Patients receive immunotherapy.

8. Patients also have other organ malignant tumor.

9. Participating in other clinical research in the same period.

10. The researchers estimate that patients cannot enter the clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Second Hospital of Jilin University

OTHER

Sponsor Role: collaborator

Jilin University

OTHER

Sponsor Role: collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

SuJun Gao

Head of Hematology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Su J Gao, PhD

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

NECOG

Identifier Type: -

Identifier Source: org_study_id