Myelodysplastic Syndromes,Acute Myeloid LeukemiaPhase 3NCT03978364
A Study of Azacitidine for Patients With Int/High -Risk MDS and AML-MRC
A Phase 3 study testing Azacitidine combined HHT and Azacitidine regimen in people with Myelodysplastic Syndromes,Acute Myeloid Leukemia, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
evaluate the clinical efficacy and safety of azacitidine combined with HAG regimen for patients with int/high -risk MDS and AML-MRC with less than 30% blasts compared with azacitidine Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myelodysplastic Syndromes,Acute Myeloid Leukemia
- What is being tested?
- Azacitidine combined HHT and Azacitidine regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 31 Dec 2022
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-75 years old, male or female;
- Int/high risk MDS AND AML patients (non-AML-M3) diagnosed according to the 2008 World Health Organization (WHO) diagnosis of myeloid malignant disease;
- The ECOG behavior status score is 0-3 points;
- The expected survival time is ≥ 3 months;
- Ability to understand and be willing to sign the informed consent form of this trial.
Who cannot join
- In the past, allergy to the drug contained in the test protocol or to a drug similar to the chemical structure of the test drug;
- There are serious active infections;
- Patients with clinically significant QTc interval prolongation (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), grade II or higher heart block, myocardial infarction (MI) Patients with coronary heart disease who have congestive heart failure (CHF) within 1 year and who are symptomatic for medical treatment;
- Heart B-ultrasound shows patients with end-diastolic pericardial cavity dark area width ≥ 10mm;
- Patients with active bleeding;
- Patients with new diseases such as thrombosis, embolism and cerebral hemorrhage in the past six months;
- Abnormal liver function (total bilirubin > 1.5 times the upper limit of normal value, 2.5 times the upper limit of ALT / AST > normal value or 5 times the upper limit of ALT / AST > normal value in patients with liver invasion), abnormal renal function (serum Creatinine > 1.5 times the upper limit of normal);
- The investigator determined that it was not suitable for the participants.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250012
Xin Wang, MD, PHD, 86-531-68778331, xinw@sdu.edu.cn
Xiaohui Sui, MD, 86-531-68778331, suzysui@163.com
About this study
Official title: An Randomized Controlled Study of Azacitidine Combined With Homoharringtonine Compared With Azacitidine for Patients With Int/High -Risk MDS and AML-MRC
evaluate the clinical efficacy and safety of azacitidine combined with HAG regimen for patients with int/high -risk MDS and AML-MRC with less than 30% blasts compared with azacitidine
Read the detailed description
Myelodysplastic syndromes (MDS) is a group of heterogeneous clonal diseases originating from hematopoietic stem cells. The most common types of acute myeloid leukemia (AML) are AML with myelodysplasia-related changes (AML-MRC) and AML-NOS. AML-MRC patients are usually with multilineage pathological hematopoiesis, previous history of MDS or MDS-related cytogenetic abnormalities. Compared with AML-NOS, AML-MRC patients are usually older, with poor prognosis of cytogenetic changes, low remission rate of chemotherapy, and worse overall prognosis. The treatment strategies mainly include demethylation drugs, chemotherapy and allogeneic hematopoietic stem cell transplantation. The main purpose of treatment is to delay disease progression, prolong survival, and even be cured.
Epigenetic changes such as DNA methylation and histone deacetylation have been considered to be involved in the occurrence and development of MDS. Demethylation drugs, such as 5-azacitidine (AZA) and 5-aza-2-deoxycytidine (decitabine), can inhibit DNA methyltransferase, reduce excessive methylation of tumor suppressor genes, promote cell differentiation and apoptosis, and play an anti-tumor role. Demethylation drugs are important therapy for MDS patients. Compared with supportive treatment, demethylation drugs can reduce the risk of AML progression and improve survival.
Therefore, we proposed this project in order to further clarify the role of azacytidine in therapy for high-risk and middle-risk MDS and AML-MRC patients, and evaluate its clinical efficacy, to explore the optimal azacytidine treatment strategies for high-risk and middle-risk MDS and AML-MRC patients.
- Being tested
- Azacitidine combined HHT, Azacitidine regimen
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacitidine combined HHTDrug
Also called Azacitidine+HHT
Azacitidine 75mg/m2，iH，qd×7days，HHT，3mg/m2 ivdrip qd×3 days
Azacitidine regimenDrug
Also called Azacitidine group
Azacitidine 75mg/m2，iH，qd×7days，28 days a cycle
| Study group | Role | What they receive |
|---|---|---|
| azacitidine | Experimental | azacitidine
azacitidine 75mg/m2，iH，qd， d1-7 Receives: Drug: Azacitidine regimen |
| azacitidine combined HHT | Active comparator | azacitidine+HHT azacitidine 75mg/m2，iH，qd， d1-7 HHT 3mg/m2,ivdrip qd,d1-3 Receives: Drug: Azacitidine combined HHT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndromes,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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang Xin, Shandong Provincial Hospital
- Investigators
- Xin Wang, MD, PhD, Principal investigator, Department of Hematology, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978364
- Sponsor's protocol ID
- ShandongPH004
- Status last verified
- Jun 2019
- First submitted
- 20 Mar 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Randomized Controlled Study of Azacitidine Combined With Homoharringtonine Compared With Azacitidine for Patients With Int/High -Risk MDS and AML-MRC
- ClinicalTrials.gov ID
- NCT03978364
- Acronym / sponsor ID
- ShandongPH004
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Jun 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.
evaluate the clinical efficacy and safety of azacitidine combined with HAG regimen for patients with int/high -risk MDS and AML-MRC with less than 30% blasts compared with azacitidine
Detailed description
Myelodysplastic syndromes (MDS) is a group of heterogeneous clonal diseases originating from hematopoietic stem cells. The most common types of acute myeloid leukemia (AML) are AML with myelodysplasia-related changes (AML-MRC) and AML-NOS. AML-MRC patients are usually with multilineage pathological hematopoiesis, previous history of MDS or MDS-related cytogenetic abnormalities. Compared with AML-NOS, AML-MRC patients are usually older, with poor prognosis of cytogenetic changes, low remission rate of chemotherapy, and worse overall prognosis. The treatment strategies mainly include demethylation drugs, chemotherapy and allogeneic hematopoietic stem cell transplantation. The main purpose of treatment is to delay disease progression, prolong survival, and even be cured.
Epigenetic changes such as DNA methylation and histone deacetylation have been considered to be involved in the occurrence and development of MDS. Demethylation drugs, such as 5-azacitidine (AZA) and 5-aza-2-deoxycytidine (decitabine), can inhibit DNA methyltransferase, reduce excessive methylation of tumor suppressor genes, promote cell differentiation and apoptosis, and play an anti-tumor role. Demethylation drugs are important therapy for MDS patients. Compared with supportive treatment, demethylation drugs can reduce the risk of AML progression and improve survival.
Therefore, we proposed this project in order to further clarify the role of azacytidine in therapy for high-risk and middle-risk MDS and AML-MRC patients, and evaluate its clinical efficacy, to explore the optimal azacytidine treatment strategies for high-risk and middle-risk MDS and AML-MRC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| azacitidine | Experimental | Drug: Azacitidine regimenazacitidine azacitidine 75mg/m2，iH，qd， d1-7 |
| azacitidine combined HHT | Active comparator | Drug: Azacitidine combined HHTazacitidine+HHT azacitidine 75mg/m2，iH，qd， d1-7 HHT 3mg/m2,ivdrip qd,d1-3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18-75 years old, male or female;
- Int/high risk MDS AND AML patients (non-AML-M3) diagnosed according to the 2008 World Health Organization (WHO) diagnosis of myeloid malignant disease;
- The ECOG behavior status score is 0-3 points;
- The expected survival time is ≥ 3 months;
- Ability to understand and be willing to sign the informed consent form of this trial.
Key exclusion criteria (8 listed)
- In the past, allergy to the drug contained in the test protocol or to a drug similar to the chemical structure of the test drug;
- There are serious active infections;
- Patients with clinically significant QTc interval prolongation (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), grade II or higher heart block, myocardial infarction (MI) Patients with coronary heart disease who have congestive heart failure (CHF) within 1 year and who are symptomatic for medical treatment;
- Heart B-ultrasound shows patients with end-diastolic pericardial cavity dark area width ≥ 10mm;
- Patients with active bleeding;
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 |
|---|---|---|
| Azacitidine combined HHTAlso: Azacitidine+HHTAzacitidine 75mg/m2，iH，qd×7days，HHT，3mg/m2 ivdrip qd×3 days | Drug | azacitidine combined HHT |
| Azacitidine regimenAlso: Azacitidine groupAzacitidine 75mg/m2，iH，qd×7days，28 days a cycle | Drug | azacitidine |
Primary outcome
Disease free survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
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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.
Xin Wang, MD, PhD principal investigator
Department of Hematology, Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azacitidine combined HHT and Azacitidine regimen in people with Myelodysplastic Syndromes,Acute Myeloid Leukemia, run by Shandong Provincial Hospital 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 5 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 7 Jun 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xin Wang, MD, PhD (86-531-68778331, xinw@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 3 years). 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 7 Jun 2019.