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Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

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ClinicalTrials.gov Identifier: NCT03021330
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
wang, jianxiang, Institute of Hematology & Blood Diseases Hospital

Brief Summary:
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.

Condition or disease Intervention/treatment Phase
AML Drug: Daunomycin and Cytarabine (DA Regimen) Drug: Daunomycin and Cytarabine (Intermediate Dose of DA Regimen) Phase 3

Detailed Description:
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine at at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/Q12h on day5-7. In the control arm, patients receive DA regimen with standard dose of cytarabine at a dose of 100mg/㎡/d on day 1-7. Patients receive consolidation therapy containing high-dose cytarabine after achieved complete remission. Stem-cell transplantation is permitted for patients with intermediate- or poor-risk disease. The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: DA Regimen
Patients receive standard DA induction regimen including daunomycin and cytarabine.
Drug: Daunomycin and Cytarabine (DA Regimen)

Cytarabine at a dose of 100mg/㎡/d on day 1-7.

Daunomycin at a dose of 60mg/㎡/d on day 1-3.

Other Name: Daunomycin and Cytarabine

Experimental: Intermediate Dose of DA Regimen
Patients receive DA induction regimen including daunomycin and intermediate dose of cytarabine.
Drug: Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)

Cytarabine at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/d on day 5-7.

Daunomycin at a dose of 60mg/㎡/d on day 1-3.

Other Name: Daunomycin and Cytarabine




Primary Outcome Measures :
  1. Overall Survival Rate (OS) [ Time Frame: Within 5 years after randomization ]
    OS is defined as the time from the date of randomization until the date of death from any cause.


Secondary Outcome Measures :
  1. Complete Remission Rate [ Time Frame: Within 2 months after randomization ]
  2. Event-Free Survival Rate [ Time Frame: Within 5 years after randomization ]
  3. Relapse-Free Survival Rate (RFS) [ Time Frame: Within 5 years after randomization ]
  4. Cumulative incidence of relapse [ Time Frame: Within 5 years after randomization ]
  5. Early Mortality [ Time Frame: within 45 days after randomization ]


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Ages Eligible for Study:   14 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of 14 to 55 years old;
  2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
  3. ECOG score ≤ 2;
  4. Patients with eligible laboratory examination including liver,renal and heart function.
  5. Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.

Exclusion Criteria:

  1. Patients who had received induction therapy.
  2. Secondary leukemia.
  3. Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
  4. Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included.
  5. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
  6. With BCR-ABL fusion gene;
  7. Pregnant or lactating women;
  8. AML with ineligible renal or liver function;
  9. AML with active cardiovascular disease;
  10. Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
  11. AIDS;
  12. Patients had central nervous system involvement when they were diagnosed as AML.
  13. Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
  14. Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
  15. Patients with other factors which were considered unsuitable to participate in the study by the investigators.

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): NCT03021330


Contacts
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Contact: Lijun Liu 86-22-23909237 bloodgcp@126.com

Locations
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China, Tianjin
Institute of Hematology & Blood Diseases Hospital Recruiting
Tianjin, Tianjin, China
Contact: lijun Liu    86-22-23909237    bloodgcp@126.com   
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
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Principal Investigator: Jianxiang Wang, Dr Institute of Hematology & Blood Diseases Hospital

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Responsible Party: wang, jianxiang, Director of Diagnosis and Treatment Center for Leukemia, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT03021330     History of Changes
Other Study ID Numbers: IIT2016007-EC-1-1
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cytarabine
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors