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

January 18, 2017 updated by: SuJun Gao, The First Hospital of Jilin University

A Prospective, Randomized, Controlled Trial of Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Patients With Acute Myeloid Leukemia With t(8;21)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • First Hospital of Jilin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Decitabine
Six cycles of decitabine IV over one hour at 20 mg/m2/day for 5 days, every 6 weeks
Drug: Decitabine
20 mg/m2/day for 5 days
ACTIVE_COMPARATOR: 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.
Drug: Daunorubicin, Cytarabine
Daunorubicin: 45 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
Drug: Mitoxantrone, Cytarabine
Mitoxantrone: 8 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
Drug: Aclacinomycin, Cytarabine
Aclacinomycin: 20 mg/day for 5 days; Cytarabine: 100 mg/m2/day for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse free survival
Time Frame: Three years
Three years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Three years
Three years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: From enrolling to two months after administrating the last course of decitabine or chemotherapy
From enrolling to two months after administrating the last course of decitabine or chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Collaborators

Second Hospital of Jilin University
The Second Affiliated Hospital of Dalian Medical University
Jilin University

Investigators

  • Study Director: Su J Gao, PhD, The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

October 1, 2024

Study Registration Dates

First Submitted

January 15, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (ESTIMATE)

January 20, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NECOG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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