Clinical trial NCT03026842: Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Acute Myeloid Leukemia With t(8;21)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myeloid Leukemia
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Dalian Medical University
name: Second Hospital of Jilin University
name: Jilin University
First posted: 2017-01-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Relapse free survival
timeFrame: Three years
Secondary outcomes:
measure: Overall survival
timeFrame: Three years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: From enrolling to two months after administrating the last course of decitabine or chemotherapy
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Su J Gao, PhD
role: STUDY_DIRECTOR
References: