Status:
RECRUITING
Dual Growth Factor (rhTPO + G-CSF) and Chemotherapy Combination Regimen in Acute Myeloid Leukemia: Study Protocol for a Randomized Controlled Trial
Lead Sponsor:
Huihan Wang
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
Acute myeloid leukemia (AML) is a disease affecting older adults, although optimal strategies for treating such patients remain unclear. This prospective phase II, openlabel, multicenter study was des...
Detailed Description
Acute myeloid leukemia (AML) is one of the most common hematologic malignancies and affects older adults. The median age at diagnosis is 67 years. As the elderly increasingly account for a greater pop...
Eligibility Criteria
Inclusion
- Age 60 or above, male or female; Acute Myeloid Leukemia (non-M3) diagnosed according to the 2008 World Health Organization (WHO) diagnostic criteria for myeloid malignancies; Newly diagnosed, no treatment for anti-leukemia; The Eastern Cooperative Oncology Group（ECOG） status score is 0 to 3 points; Expected survival time ≥ 3 months; No serious heart, lung, liver or kidney disease; History of no thromboembolism Ability to understand and be willing to sign the informed consent form of this trial.
Exclusion
- used to be allergic to the drugs contained in the protocol or to drugs similar in chemical structure to the test drugs; serious active infections; Patients with extramedullary lesions; Patients who use drugs and long-term alcohol abuse to influence the evaluation of test results; Inability to obtain informed consent and cannot complete the trial treatment and examination procedures because of mental illness or other conditions Patients with clinically significant corrected QT interval (QTc) prolongation (male \> 450ms, female \> 470ms), Ventricular Tachycardia (VT), Atrial Fibrillation (AF), grade II or higher heart block, Myocardial Infarction (MI) within 1 year, Congestive Heart Failure (CHF), coronary heart disease with symptoms who need medical treatment; Abnormal liver function (total bilirubin \> 1.5 times the upper limit of normal value, Alanine aminotransferase(ALT) / Aspartate aminotransferase (AST) \>2.5 times the upper limit of normal value or ALT / AST in patients with liver invasion \> 5 times the upper limit of normal value of normal), abnormal renal function (serum Creatinine \> 1.5 times the upper limit of normal); The investigator determine that the participants are not suitable
Key Trial Info
Start Date :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 21 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05382390
Start Date
January 21 2022
End Date
January 21 2026
Last Update
May 19 2022
Active Locations (1)
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1
ShengJing Hospital of China Medical University
Shenyang, Liaoning, China, 110004