Combination of growth factors and chemotherapy for elderly patients with acute myeloid leukemia
Dual Growth Factor (rhTPO + G-CSF) and Chemotherapy Combination Regimen for Elderly Patients With Acute Myeloid Leukemia: A Phase II Single-Arm Multicenter Study
This study is testing a new combination of growth factors and chemotherapy to see if it can help older patients with newly diagnosed acute myeloid leukemia feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| 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 | NCT05258799 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a combination regimen involving recombinant human thrombopoietin (rhTPO) and granulocyte colony-stimulating factor (G-CSF) alongside decitabine, cytarabine, and aclarubicin in treating elderly patients newly diagnosed with acute myeloid leukemia (AML). The study is designed as a phase II, open-label, multicenter trial, focusing on older adults who often face poor outcomes with standard treatments. Participants will receive a specific dosing schedule of these agents, and their responses will be monitored against historical controls treated with a different regimen. The goal is to improve overall response rates and survival outcomes for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 60 and above who have newly diagnosed acute myeloid leukemia and meet specific health criteria.
Not a fit: Patients with serious active infections, extramedullary lesions, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and survival rates for elderly patients with acute myeloid leukemia.
How similar studies have performed: Previous studies have shown some success with similar combinations of growth factors and chemotherapy in treating AML, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion Criteria: 1. Age 60 or above, male or female; 2. Acute Myeloid Leukemia (non-M3) diagnosed according to the 2008 World Health Organization (WHO) diagnostic criteria for myeloid malignancies; 3. Newly diagnosed, no treatment for anti-leukemia; 4. The Eastern Cooperative Oncology Group（ECOG） status score is 0 to 3 points; 5. Expected survival time ≥ 3 months; 6. No serious heart, lung, liver or kidney disease; 7. History of no thromboembolism 8. Ability to understand and be willing to sign the informed consent form of this trial. Exclusion Criteria: Exclusion Criteria: 1. used to be allergic to the drugs contained in the protocol or to drugs similar in chemical structure to the test drugs; 2. serious active infections; 3. Patients with extramedullary lesions; 4. Patients who use drugs and long-term alcohol abuse to influence the evaluation of test results; 5. Inability to obtain informed consent and cannot complete the trial treatment and examination procedures because of mental illness or other conditions 6. 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; 7. 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); 8. 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
- Principal investigator: Huihan Wang, Doctor — Shengjing Hospital
- 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.