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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03026842
Recruitment Status : Active, not recruiting
First Posted : January 20, 2017
Last Update Posted : January 20, 2017
Sponsor:
Collaborators:
The Second Affiliated Hospital of Dalian Medical University
Second Hospital of Jilin University
Jilin University
Information provided by (Responsible Party):
SuJun Gao, First Hospital of Jilin University

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Decitabine Drug: Daunorubicin, Cytarabine Drug: Mitoxantrone, Cytarabine Drug: Aclacinomycin, Cytarabine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : January 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : October 2024


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




Primary Outcome Measures :
  1. Relapse free survival [ Time Frame: Three years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Three years ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026842


Locations
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China, Jilin
First Hospital of Jilin University
Changchun, Jilin, China, 130021
Sponsors and Collaborators
First Hospital of Jilin University
The Second Affiliated Hospital of Dalian Medical University
Second Hospital of Jilin University
Jilin University
Investigators
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Study Director: Su J Gao, PhD First Hospital of Jilin University

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Responsible Party: SuJun Gao, Head of Hematology Department, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT03026842    
Other Study ID Numbers: NECOG
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Decitabine
Daunorubicin
Mitoxantrone
Aclacinomycins
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Immunologic