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

NCT03026842 | Unknown Phase 4

• 1 other identifier: NECOG
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Relapse free survival

  Three years

Secondary Outcomes (2)

• 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

Study Arms (2)

Decitabine

EXPERIMENTAL

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

Drug: Decitabine

Conventional chemotherapy

ACTIVE COMPARATOR

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; Drug: Mitoxantrone, Cytarabine; Drug: Aclacinomycin, Cytarabine

Interventions

Decitabine DRUG

20 mg/m2/day for 5 days

Decitabine

Daunorubicin, Cytarabine DRUG

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

Conventional chemotherapy

Mitoxantrone, Cytarabine DRUG

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

Conventional chemotherapy

Aclacinomycin, Cytarabine DRUG

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

Conventional chemotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• Second Hospital of Jilin University: collaborator
• Jilin University: collaborator

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine; Daunorubicin; Cytarabine; NOAC protocol; aclacinomycins

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Arabinonucleosides

Study Officials

• Su J Gao, PhD

  The First Hospital of Jilin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hematology Department

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: January 20, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2023
• Study Completion: October 1, 2024
• Last Updated: January 20, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)