Acute Myeloid LeukemiaNCT04168138
D-CTAG in the Treatment of Newly Diagnosed Acute Myeloid Leukemia in Elderly Patients
A study testing rhTPO in people with Acute Myeloid Leukemia, run by Huihan Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- rhTPO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ShengJing Hospital of China Medical University
Shenyang, Liaoning, 110004
Huihan Wang, Doctor, +86 18940256966, wanghh24115@outlook.com
About this study
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.
Read the detailed description
In China，the incidence of leukemia is 2.76/100,000. Leukemia ranks first in the mortality rate of malignant tumors in children and adults under 35 years old. 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.In 1995, Japanese scholar Yamada proposed the CAG protocol (granulocyte colony-stimulating factor (G-CSF) combined with low-dose cytarabine (Ara-C) and aclacinomycin (ACR)) for the treatment of Acute Myeloid leukemia in elderly patients.when a better response rate was obtained, the side effects were significantly reduced. Although the application of G-CSF in the CAG protocol reduces the incidence of granulocytopenic co-infection in elderly patients, thrombocytopenia, another common side effect of chemotherapy in elderly patients, still limits the efficacy and safety of treatment in elderly patients. Recombinant human thrombopoietin (rhTPO) is approved for thrombocytopenia after solid tumor chemotherapy, but there are few studies on Acute Myeloid Leukemia (AML).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.Recent studies have found that erythropoietin and G-CSF act on the cardiovascular system.By mobilizing bone marrow stem cells to repair ischemic myocardium,they promote cardiomyocyte regeneration and neovascularization in the ischemic area. In addition to promoting platelet growth, rhTPO can also reduce the cardiotoxicity of anthracyclines in elderly patients with CAG.We provide a safe and effective chemotherapy for elderly leukemia patients, so that more elderly patients receive chemotherapy,which has important practical significance.
The cycle of this trial is 8 cycles.After all the treatments completing, the patients are followed up to observe the bone marrow.In the first year,the patients will be reviewed every 3 months;In the second year ,They will be reviewed every 6 months, and two year later,they will be reviewed every year, including morphological analysis of bone marrow.After the trial is completed, the survival information of the patients will be followed up by telephone or through the trial center every 3 months.
About combined medication:1) During the whole test period, patients are not allowed to receive other anti-tumor measures other than test drugs, including radiotherapy, chemotherapy, targeted therapy, immunological preparation, hematopoietic stem cell transplantation, etc.;2) The investigator can take appropriate supportive treatment after evaluating the relationship between adverse events and trial medication. The start and duration of supportive treatment are recorded in the original record. These treatments include antiemetics, antidiarrheal, antipyretic, antiallergic, diabetes treatment, use of antihypertensive drugs, use of analgesics, use of antibiotics, and other uses such as blood products;3)The patients can be given symptomatic treatment when hematological toxicity is in level 3 or after the investigator has judged the condition, and record in the combined medication;4)The patients can be given symptomatic treatment when non-hematological toxicity is in level 2 and record in the combined medication;5) Basic diseases should be given to maintain treatment;6) All concomitant medications, generic names, medication purposes, dosages, and medication time received by the patient should be fully recorded in the original record;7) It is forbidden to use other clinical trial drugs during the trial.
The use of TPO in new technologies may increase the incidence of thrombosis. In this trial, rhTPO will be discontinued when platelets > 50*109/L. Because of chemotherapy, bone marrow suppression and thrombocytopenia are observed. At the same time, newly diagnosed leukemia often combined with thrombocytopenia. No special medication will be needed to prevent thrombosis, and platelet level should be closely observed. Other technologies, other risks and response plans are the same as traditional treatment plans The cost of patient medication in this trial is similar to that of traditional treatment . The chemotherapy drugs used are all listed drugs
- Conditions
- Acute Myeloid Leukemia
- Being tested
- rhTPO
- Keywords
- D-CTAG, Acute Myeloid Leukemia, rhTPO
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPODrug
Also called Decitabine, Aclarubicin, G-CSF, Cytarabine
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: rhTPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival（PFS）
Progression free survival
Measured: 2 years after the end of treatment of the last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Nov 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huihan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huihan Wang, Shengjing Hospital
- Investigators
- Huihan Wang, Doctor, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168138
- Sponsor's protocol ID
- HhWang
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-CTAG in the Treatment of Newly Diagnosed Acute Myeloid Leukemia in Elderly Patients
- ClinicalTrials.gov ID
- NCT04168138
- Acronym / sponsor ID
- HhWang
- Conditions
- Acute Myeloid Leukemia
- Keywords
- D-CTAG, Acute Myeloid Leukemia, rhTPO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Huihan WangUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In China，the incidence of leukemia is 2.76/100,000. Leukemia ranks first in the mortality rate of malignant tumors in children and adults under 35 years old. 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.In 1995, Japanese scholar Yamada proposed the CAG protocol (granulocyte colony-stimulating factor (G-CSF) combined with low-dose cytarabine (Ara-C) and aclacinomycin (ACR)) for the treatment of Acute Myeloid leukemia in elderly patients.when a better response rate was obtained, the side effects were significantly reduced. Although the application of G-CSF in the CAG protocol reduces the incidence of granulocytopenic co-infection in elderly patients, thrombocytopenia, another common side effect of chemotherapy in elderly patients, still limits the efficacy and safety of treatment in elderly patients. Recombinant human thrombopoietin (rhTPO) is approved for thrombocytopenia after solid tumor chemotherapy, but there are few studies on Acute Myeloid Leukemia (AML).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.Recent studies have found that erythropoietin and G-CSF act on the cardiovascular system.By mobilizing bone marrow stem cells to repair ischemic myocardium,they promote cardiomyocyte regeneration and neovascularization in the ischemic area. In addition to promoting platelet growth, rhTPO can also reduce the cardiotoxicity of anthracyclines in elderly patients with CAG.We provide a safe and effective chemotherapy for elderly leukemia patients, so that more elderly patients receive chemotherapy,which has important practical significance.
The cycle of this trial is 8 cycles.After all the treatments completing, the patients are followed up to observe the bone marrow.In the first year,the patients will be reviewed every 3 months;In the second year ,They will be reviewed every 6 months, and two year later,they will be reviewed every year, including morphological analysis of bone marrow.After the trial is completed, the survival information of the patients will be followed up by telephone or through the trial center every 3 months.
About combined medication:1) During the whole test period, patients are not allowed to receive other anti-tumor measures other than test drugs, including radiotherapy, chemotherapy, targeted therapy, immunological preparation, hematopoietic stem cell transplantation, etc.;2) The investigator can take appropriate supportive treatment after evaluating the relationship between adverse events and trial medication. The start and duration of supportive treatment are recorded in the original record. These treatments include antiemetics, antidiarrheal, antipyretic, antiallergic, diabetes treatment, use of antihypertensive drugs, use of analgesics, use of antibiotics, and other uses such as blood products;3)The patients can be given symptomatic treatment when hematological toxicity is in level 3 or after the investigator has judged the condition, and record in the combined medication;4)The patients can be given symptomatic treatment when non-hematological toxicity is in level 2 and record in the combined medication;5) Basic diseases should be given to maintain treatment;6) All concomitant medications, generic names, medication purposes, dosages, and medication time received by the patient should be fully recorded in the original record;7) It is forbidden to use other clinical trial drugs during the trial.
The use of TPO in new technologies may increase the incidence of thrombosis. In this trial, rhTPO will be discontinued when platelets > 50*109/L. Because of chemotherapy, bone marrow suppression and thrombocytopenia are observed. At the same time, newly diagnosed leukemia often combined with thrombocytopenia. No special medication will be needed to prevent thrombosis, and platelet level should be closely observed. Other technologies, other risks and response plans are the same as traditional treatment plans The cost of patient medication in this trial is similar to that of traditional treatment . The chemotherapy drugs used are all listed drugs
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed AML in elderly patient | Experimental | Drug: rhTPOD: 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhTPOAlso: Decitabine, Aclarubicin, G-CSF, CytarabineD: 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 | Drug | Newly diagnosed AML in elderly patient |
Primary outcome
Progression free survival（PFS）
Time frame: 2 years after the end of treatment of the last patient enrolled
Progression free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huihan Wang, Doctor principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhTPO in people with Acute Myeloid Leukemia, run by Huihan Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huihan Wang, Doctor (+86 18940256966, wanghh24115@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival（PFS） (time frame: 2 years after the end of treatment of the last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.