Clinical trial · Interventional
A Study of Azacitidine for Patients With Int/High -Risk MDS and AML-MRC
An Randomized Controlled Study of Azacitidine Combined With Homoharringtonine Compared With Azacitidine for Patients With Int/High -Risk MDS and AML-MRC
NCT03978364CI-TRIAL-00038990unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Syndromes,Acute Myeloid Leukemia | Myelodysplastic Syndrome | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine combined HHT | Drug | — | UNRESOLVED |
| Azacitidine regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- azacitidine
- description
- azacitidine azacitidine 75mg/m2,iH,qd, d1-7
- interventionNames
- Drug: Azacitidine regimen
- type
- ACTIVE_COMPARATOR
- label
- azacitidine combined HHT
- description
- azacitidine+HHT azacitidine 75mg/m2,iH,qd, d1-7 HHT 3mg/m2,ivdrip qd,d1-3
- interventionNames
- Drug: Azacitidine combined HHT
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.