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

NCT04168138 | Unknown DMC

• 1 other identifier: HhWang
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia

Keywords

D-CTAG; Acute Myeloid Leukemia; rhTPO

Outcome Measures

Primary Outcomes (1)

• Progression free survival（PFS）

  Progression free survival

  2 years after the end of treatment of the last patient enrolled

Study Arms (1)

Newly diagnosed AML in elderly patient

EXPERIMENTAL

D: Decitabine(15mg/m2) d1-5 G: G-CSF（300ug/d） d0-9(stop using when WBC\>20\*109/L) T: rhTPO(15000U/d) d3,5,7,9, d11- (Platelet\>50\*109/L) A: Aclarubicin(10mg/d) d3-6 C: Cytarabine(15mg Q12h) d3-9

Drug: rhTPO

Interventions

rhTPO DRUG

D: Decitabine(15mg/m2) d1-5 G: G-CSF（300ug/d） d0-9(stop using when White Blood Cell (WBC)\>20\*109/L) T: rhTPO(15000U/d) d3,5,7,9, d11- (Platelet\>50\*109/L) A: Aclarubicin(10mg/d) d3-6 C: Cytarabine(15mg Q12h) d3-9

Also known as: Decitabine, Aclarubicin, G-CSF, Cytarabine

Newly diagnosed AML in elderly patient

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Huihan Wang: lead

Study Sites (1)

ShengJing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine; Aclarubicin; Granulocyte Colony-Stimulating Factor; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Arabinonucleosides

Study Officials

• Huihan Wang, Doctor

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huihan Wang, Doctor

CONTACT

+86 18940256966; wanghh24115@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 19, 2019
• Study Start: November 1, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2024
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)