D-CTAG in the Treatment of Newly Diagnosed Acute Myeloid Leukemia in Elderly Patients

• Status: Recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

With the aging of society, the incidence of elderly leukemia in China has been increasing year by year. The elderly patients with Acute Leukemia have poor basal state, and there are many important organ diseases such as heart, liver and kidney. The incidence of infection and hemorrhage is high in elderly patients after chemotherapy. These characteristics make the treatment of elderly leukemia difficult. So we propose a new treatment plan by using the therapy that rhTPO may promote the leukemia cells into the division cycle.We use the synergistic effect of G-CSF and rhTPO to promote leukemia cells into the division cycle, thereby the cells can be killed by cytotoxic drugs. At the same time, G-CSF and rhTPO are used to promote the growth of granulocytes and platelets, therefore the side effects of treatment of elderly leukemia can be alleviated. We provide a safe and effective chemotherapy for elderly leukemia patients, so that more elderly patients receive chemotherapy,which has important practical significance.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huihan Wang
• Treatments: Aclarubicin; Cytarabine; Decitabine

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:

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