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A Study of Azacitidine for Patients With Int/High -Risk MDS and AML-MRC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03978364
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Information provided by (Responsible Party):
Wang Xin, Shandong Provincial Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes,Acute Myeloid Leukemia Drug: Azacitidine combined HHT Drug: Azacitidine regimen Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Randomized Controlled Study of Azacitidine Combined With Homoharringtonine Compared With Azacitidine for Patients With Int/High -Risk MDS and AML-MRC
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: azacitidine


azacitidine 75mg/m2,iH,qd, d1-7

Drug: Azacitidine regimen
Azacitidine 75mg/m2,iH,qd×7days,28 days a cycle
Other Name: Azacitidine group

Active Comparator: azacitidine combined HHT
azacitidine+HHT azacitidine 75mg/m2,iH,qd, d1-7 HHT 3mg/m2,ivdrip qd,d1-3
Drug: Azacitidine combined HHT
Azacitidine 75mg/m2,iH,qd×7days,HHT,3mg/m2 ivdrip qd×3 days
Other Name: Azacitidine+HHT

Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Aged between 18-75 years old, male or female;
  2. Int/high risk MDS AND AML patients (non-AML-M3) diagnosed according to the 2008 World Health Organization (WHO) diagnosis of myeloid malignant disease;
  3. The ECOG behavior status score is 0-3 points;
  4. The expected survival time is ≥ 3 months;
  5. Ability to understand and be willing to sign the informed consent form of this trial.

Exclusion Criteria:

  1. 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;
  2. There are serious active infections;
  3. 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;
  4. Heart B-ultrasound shows patients with end-diastolic pericardial cavity dark area width ≥ 10mm;
  5. Patients with active bleeding;
  6. Patients with new diseases such as thrombosis, embolism and cerebral hemorrhage in the past six months;
  7. 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);
  8. The investigator determined that it was not suitable for the participants.

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 identifier (NCT number): NCT03978364

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Contact: Xin Wang, MD, PhD 86-531-68778331

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China, Shandong
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China, 250012
Contact: Xin Wang, MD, PHD    86-531-68778331   
Contact: Xiaohui Sui, MD    86-531-68778331   
Sponsors and Collaborators
Shandong Provincial Hospital
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Principal Investigator: Xin Wang, MD, PhD Department of Hematology, Shandong Provincial Hospital

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Responsible Party: Wang Xin, director of hematology, Shandong Provincial Hospital Identifier: NCT03978364     History of Changes
Other Study ID Numbers: ShandongPH004
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Leukemia, Myeloid
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors