Clinical trial · Interventional
Azacytidine + HAG Regimen vs. Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy
The Efficacy and Safety of Azacytidine Combined With HAG Regimen Versus Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy: a Prospective, Randomized Controlled Trial
- 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)
The primary objective is to explore the efficacy and safety of azacytidine and HAG regimen versus azacytidine for elderly patients with Newly Diagnosed MDS/AML/CMML in China. This is a post-marketing, interventional, multi-center, double-arm, prospective, open-label, randomized controlled study in elderly patients with MDS/AML/CMML in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given azacytidine + HAG regimen or azacytidine under the conditions of informed consent and frequent monitoring according to the clinical guideline.
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 |
|---|---|---|---|
| Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacytidine | Drug | Azacitidine | ALIAS |
| Azacytidine, HAG Regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Azacytidine + HAG Regimen
- description
- Azacytidine（75mg/m2 ）+ HAG Regimen（Homoharringtonine(HHT) 1mg/(m2.d) , Cytarabine 10mg/(m2.d), G-CSF 200ug/(m2.d) )
- interventionNames
- Drug: Azacytidine, HAG Regimen
- type
- ACTIVE_COMPARATOR
- label
- Azacytidine
- description
- 75mg/m2
- interventionNames
- Drug: Azacytidine
Primary outcomes (1)
- measure
- Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments.
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 60; * Patients with newly diagnoised diseases including MDS/AML/CMML; * The ECOG behavior status score is less than 3 points; * Agree to sign informed consent Exclusion Criteria: * Patients with a history of sever heart disease; * Patients with severe organ dysfunction; * Patients with other malignancies * Patients who are allergic to the treatment of drug ingredients
References
Publications (0)
Data not yet available