Status:
UNKNOWN
IA14 Induction in Young Acute Myeloid Leukemia
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 c...
Eligibility Criteria
Inclusion
- 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
- 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;
- 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;
Key Trial Info
Start Date :
September 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04069208
Start Date
September 3 2019
End Date
December 31 2021
Last Update
June 8 2021
Active Locations (1)
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1
Xinxin Cao
Beijing, Beijing Municipality, China, 100038