IA14 Induction in Young Acute Myeloid Leukemia

NCT ID: NCT04069208

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-03
• Study Completion Date: 2021-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IA14

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

Group Type: EXPERIMENTAL

Idarubicin and cytarabine induction

Intervention Type: DRUG

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

Interventions

Idarubicin and cytarabine induction

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

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cao Xinxin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Li, M.D.

Role: STUDY_DIRECTOR

Peking Union Medical College Hospital

Locations

Xinxin Cao

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinxin Cao

Role: CONTACT

caoxinxin@pumch.cn

69155027

Facility Contacts

Xinxin Cao

Role: primary

caoxinxin@pumch.cn

Other Identifiers

AML-IA14

Identifier Type: -

Identifier Source: org_study_id