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IA14 Induction in Young Acute Myeloid Leukemia

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069208
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Cao Xinxin, Peking Union Medical College Hospital

Brief Summary:
Acute myeloid leukemia (AML) is a clinically and biologically heterogeneous disease characterized by the clonal expansion of undifferentiated myeloid precursors. Although induction chemotherapy with cytarabine and daunorubicin/Idarubicin, typically called "7+3", has not changed for several decades, the best dosage of anthracycline is still unknown. Several prospective trials have demonstrated that intense dosage of anthracycline improved complete remission (CR) and overall survival (OS). Idarubicin 12mg/m2 (IA12) has been shown to be equal to dose intense daunorubicin (90 mg/m2 ) for achieving CR. Dose-intense daunorubicin 90 mg/m2 (DA90) has been shown to improve CR compared to standard dose daunorubucin 45mg/m2 in newly diagnosed AML patients. In our previous study, CR rate of induction with daunorubicin 60 mg/m2/d (3 days) and cytarabine 200 mg/m2/d days 1-7 was about 67%. Benefit of intensification seems limited to the patients without adverse cytogenetics. Wheher ultra high dose idarubicin 14mg/m2 (IA14) could further improve CR rate, give patients with adverse cytogenetics a chance to do allo-stem cell transplantation? This phase 2, prospective, single-center study is designed to evaluate the efficacy and safety of induction with idarubicin 14mg/m2/d (3 days) and cytarabine 200 mg/m2/d days 1-7 in young newly diagnosed AML patients.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Idarubicin and cytarabine induction Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Idarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose-intense Idarubicin Induction in Young Patients With Acute Myeloid Leukemia
Actual Study Start Date : September 3, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: IA14
Idarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days
Drug: Idarubicin and cytarabine induction
Idarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days




Primary Outcome Measures :
  1. Complete remission (CR) rate [ Time Frame: On Day 21 (window Day 21 to Day 30), a bone marrow aspirate specimen will be collected for pathology. ]
    the rate of patient who get CR after induction therapy


Secondary Outcome Measures :
  1. Event-free survival (EFS) [ Time Frame: Assessed up to 24 months. Event is defined as any of the following: 1)Refractory disease (or treatment failure) which is determined at the end of the Induction Phase; 2)Relapse after CR or CRi; 3)Death from any cause at any time during the study. ]
    EFS is defined as the duration from initiation of IA induction treatment to the date of a first event

  2. Overall survival (OS) [ Time Frame: OS was defined as the duration from initiation of IA induction treatment to the date of death or last follow-up assessed up to 24 months. ]
    OS was defined as the duration from initiation of IA induction treatment to the date of death or last follow-up

  3. rate of Minimal Residual Disease (MRD) negativity [ Time Frame: MRD will be tested after on Day 21 (window Day 21 to Day 30) ]
    Percentage of subjects achieving CR with no evidence of Minimal Residual Disease (MRD) following induction therapy.



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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:

  • Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008 classification (at Screening)
  • Must be competent and able to comprehend, sign, and date an Ethics Committee or Institutional Review Board approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests;
  • ≥18 yearsand ≤60 years (at Screening);
  • Eastern Cooperative Oncology Group performance status 0-2 (at Screening);
  • Adequate renal function defined as: Creatinine clearance rate >50 mL/min, as calculated with the modified Cockcroft Gault equation;
  • Adequate hepatic function defined as: Total serum bilirubin ≤1.5 × ULN; and serum alkaline phosphatase, aspartate transaminase and alanine transaminase ≤2.5 × ULN;
  • Serum electrolytes within normal limits: potassium, calcium (total or corrected for serum albumin in case of hypoalbuminemia). If outside of normal limits, subject will be eligible when electrolytes are corrected;

Exclusion Criteria:

  • Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12); subjects who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
  • Prior treatment for AML, except for the following allowances:

    1. Leukapheresis;
    2. Treatment for hyperleukocytosis with hydroxyurea;
    3. Growth factor/cytokine support;
  • Uncontrolled or significant cardiovascular disease, including any of the following:

    1. Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;
    2. Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
    3. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
    4. History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
    5. History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
    6. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
    7. History of New York Heart Association Class 3 or 4 heart failure;
    8. Complete left bundle branch block;
    9. Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;
  • Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
  • Concurrent of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease
  • Females who are pregnant or breastfeeding;

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): NCT04069208


Contacts
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Contact: Xinxin Cao 69155027 caoxinxin@pumch.cn

Locations
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China, Beijing
Xinxin Cao Recruiting
Beijing, Beijing, China, 100038
Contact: Xinxin Cao       caoxinxin@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Director: Jian Li, M.D. Peking Union Medical College Hospital
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Responsible Party: Cao Xinxin, Associate Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04069208    
Other Study ID Numbers: AML-IA14
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cao Xinxin, Peking Union Medical College Hospital:
Acute Myeloid Leukemia
ultra-high dose idarubicin
induction
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Idarubicin
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