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

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ClinicalTrials.gov Identifier: NCT04168138
Recruitment Status : Recruiting
First Posted : November 19, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Huihan Wang, Shengjing Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: rhTPO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: D-CTAG in the Treatment of Newly Diagnosed Acute Myeloid Leukemia in Elderly Patients
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2024


Arm Intervention/treatment
Experimental: Newly diagnosed AML in elderly patient
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
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
Other Names:
  • Decitabine
  • Aclarubicin
  • G-CSF
  • Cytarabine




Primary Outcome Measures :
  1. Progression free survival(PFS) [ Time Frame: 2 years after the end of treatment of the last patient enrolled ]
    Progression free survival



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04168138


Contacts
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Contact: Huihan Wang, Doctor +86 18940256966 wanghh24115@outlook.com

Locations
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China, Liaoning
ShengJing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
Contact: Huihan Wang, Doctor    +86 18940256966    wanghh24115@outlook.com   
Sponsors and Collaborators
Huihan Wang
Investigators
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Principal Investigator: Huihan Wang, Doctor Shengjing Hospital

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Responsible Party: Huihan Wang, Deputy Chief Physician, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT04168138    
Other Study ID Numbers: HhWang
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Huihan Wang, Shengjing Hospital:
D-CTAG
Acute Myeloid Leukemia
rhTPO
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Decitabine
Aclarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors