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

Acute Myeloid Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03026842
• Other study ID #: NECOG
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 15, 2017
• Last updated: January 18, 2017
• Start date: January 2017
• Est. completion date: October 2024

Study information

• Verified date: January 2017
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: October 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Decitabine
20 mg/m2/day for 5 days
• Daunorubicin, Cytarabine
Daunorubicin: 45 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
• Mitoxantrone, Cytarabine
Mitoxantrone: 8 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
• Aclacinomycin, Cytarabine
Aclacinomycin: 20 mg/day for 5 days; Cytarabine: 100 mg/m2/day for 5 days

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (4)

Lead Sponsor	Collaborator
First Hospital of Jilin University	Jilin University, Second Hospital of Jilin University, The Second Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse free survival		Three years
Secondary	Overall survival		Three years
Secondary	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