A Prospective, Randomized, Controlled Trial of Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Patients With Acute Myeloid Leukemia With t(8;21)
Overview
- Phase
- Phase 4
- Intervention
- Decitabine
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- The First Hospital of Jilin University
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Relapse free survival
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
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.
Investigators
SuJun Gao
Head of Hematology Department
The First Hospital of Jilin University
Eligibility Criteria
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 \>
- •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.
Arms & Interventions
Decitabine
Six cycles of decitabine IV over one hour at 20 mg/m2/day for 5 days, every 6 weeks
Intervention: Decitabine
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.
Intervention: Daunorubicin, Cytarabine
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.
Intervention: Mitoxantrone, Cytarabine
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.
Intervention: Aclacinomycin, Cytarabine
Outcomes
Primary Outcomes
Relapse free survival
Time Frame: Three years
Secondary Outcomes
- 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)