Combination of growth factors and chemotherapy for treating acute myeloid leukemia in older adults
Dual Growth Factor (rhTPO + G-CSF) and Chemotherapy Combination Regimen in Acute Myeloid Leukemia: Study Protocol for a Randomized Controlled Trial
This study is testing a new treatment combining growth factors and chemotherapy to see if it can help older adults with acute myeloid leukemia feel better and improve their chances of recovery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Shengjing Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT05382390 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a combination regimen involving recombinant human thrombopoietin (rhTPO) and granulocyte colony-stimulating factor (G-CSF) alongside chemotherapy agents decitabine, cytarabine, and aclarubicin in older adults diagnosed with acute myeloid leukemia (AML). The study aims to improve treatment outcomes for this population, which has historically faced poor prognosis due to age-related factors and comorbidities. Participants will receive the treatment over a specified schedule, and their responses will be monitored against historical controls receiving standard therapy. The trial is designed to provide insights into a potentially more effective treatment strategy for elderly AML patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 60 and above who have newly diagnosed acute myeloid leukemia and meet specific health criteria.
Not a fit: Patients with serious comorbidities, active infections, or those who have previously received treatment for leukemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for older adults with acute myeloid leukemia.
How similar studies have performed: Previous studies have shown promising results with similar combinations of growth factors and chemotherapy in treating acute myeloid leukemia, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Shenyang, Liaoning
- ShengJing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Huihan Wang, Doctor
- Email: wanghh24115@outlook.com
- Phone: +86 18940256966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.