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Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT03031249
Recruitment Status : Recruiting
First Posted : January 25, 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, nucleophosmin-1(NPM1) mutated acute myeloid leukemia (AML) patients who have reached CR are randomized into two groups.The control group receive high-dose cytarabine(HDAC) regimen while the experimental group receive high dose of cytarabine plus tretinoin(ATRA) and arsenic trioxide(ATO) treatment.The safety and efficacy of ATRA and ATO is evaluated.

Condition or disease Intervention/treatment Phase
AML Drug: Cytarabine Drug: all-trans retinoic acid Drug: Arsenic Trioxide Phase 1 Phase 2

Detailed Description:

In this open-label, randomized, prospective clinical trial, NPM1- mutated AML patients who have reached CR are randomized into two groups.

In experimental group, patients receive cytarabine at a dose of 3g/㎡/d on the first, third and fifth day, ATRA at a dose of 30mg/㎡/d on day 1-14 and ATO at a dose of 0.15mg/kg/d (maximum, 10mg/d) on day 1-14. Patients in control group only receive high dose of cytarabine.

The safety and efficacy of ATRA plus ATO regimen is evaluated.The primary outcome is relapse-free survival rate after treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Active Comparator: High Dose of Cytarabine
Patients receive high dose of cytarabine.
Drug: Cytarabine
Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day.
Other Name: HDAC

Experimental: HDAC + ATRA + ATO
Patients receive high dose of cytarabine plus ATRA and ATO treatment.
Drug: Cytarabine
Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day.
Other Name: HDAC

Drug: all-trans retinoic acid
ATRA at a dose of 30mg/㎡/d on day 1-14.
Other Name: ATRA

Drug: Arsenic Trioxide
ATO at a dose of 10mg/d on day 1-14
Other Name: ATO




Primary Outcome Measures :
  1. Relapse-Free Survival Rate (RFS) [ Time Frame: Within 5 years after randomization ]
    RFS is defined as the time from the date of complete remission (CR) after entry in this trial until the date of documented relapse or death for NPM1 mutated leukemia patients who achieve CR.


Secondary Outcome Measures :
  1. Non-relapse Mortality [ Time Frame: through treatment completion, an average of 5 months ]
  2. Overall Survival Rate (OS) [ Time Frame: Within 5 years after randomization ]
  3. Cumulative incidence of relapse [ Time Frame: Within 5 years after randomization ]


Information from the National Library of Medicine

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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) and with NPM1-mutated.
  3. Reached CR after induction regimen.
  4. ECOG score of ≤ 2;
  5. Patients with eligible laboratory examination including liver,renal and heart function.
  6. 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. Secondary leukemia.
  2. Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
  3. 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.
  4. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
  5. With BCR-ABL fusion gene;
  6. Pregnant or lactating women;
  7. With ineligible renal or liver function;
  8. With active cardiovascular disease;
  9. Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
  10. AIDS;
  11. Patients had central nervous system involvement when they were diagnosed as AML.
  12. Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
  13. Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
  14. 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): NCT03031249


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 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: NCT03031249     History of Changes
Other Study ID Numbers: IIT2016007-EC-1-2
First Posted: January 25, 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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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Arsenic Trioxide
Tretinoin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Keratolytic Agents
Dermatologic Agents