IA14 Induction in Young Acute Myeloid Leukemia

NCT04069208 | Unknown Phase 2

• 1 other identifier: AML-IA14
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; ultra-high dose idarubicin; induction

Outcome Measures

Primary Outcomes (1)

• Complete remission (CR) rate

  the rate of patient who get CR after induction therapy

  On Day 21 (window Day 21 to Day 30), a bone marrow aspirate specimen will be collected for pathology.

Secondary Outcomes (3)

• Event-free survival (EFS)

  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.

• Overall survival (OS)

  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.

• rate of Minimal Residual Disease (MRD) negativity

  MRD will be tested after on Day 21 (window Day 21 to Day 30)

Study Arms (1)

IA14

EXPERIMENTAL

Idarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days

Drug: Idarubicin and cytarabine induction

Interventions

Idarubicin and cytarabine induction DRUG

Idarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days

IA14

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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:
• Leukapheresis;
• Treatment for hyperleukocytosis with hydroxyurea;
• Growth factor/cytokine support;
• Uncontrolled or significant cardiovascular disease, including any of the following:
• Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;
• Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
• Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
• History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
• 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);
• History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
• History of New York Heart Association Class 3 or 4 heart failure;
• Complete left bundle branch block;
• Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Xinxin Cao

Beijing, Beijing Municipality, 100038, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Idarubicin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Jian Li, M.D.

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

Xinxin Cao

CONTACT

69155027; caoxinxin@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Idarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: September 3, 2019
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

CN (1)