CMML, MDS
Conditions
Keywords
MDS, CMML, Venetoclax, Hypomethylating agents
Brief summary
The aim of this study is to observe and analyze the clinical efficacy of Venetoclax+HMAs regimen in the treatment of newly diagnosed higher-risk MDS and CMML cases, and to compare the efficacy of venetoclax +HMAs regimen with that of HMAS regimen alone, in order to provide a normative scheme and basis for clinical use.
Interventions
DRUGVenetoclax
Previous phase Ib studies have fully demonstrated that venetoclax combined with HMAs is well tolerated in patients with MDS or CMML. Patients treated with VEN/AZA had a higher chance of SCT after remission and a higher survival benefit
Sponsors
Guangdong Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old, male or female; 2. MDS or CMML diagnosed by the 2016 or 222 WHO criteria, with a sustained survival of at least 12 weeks; 3. received more than two cycles of Venetoclax plus HMAs or HMAs alone without prior disease specific or allogeneic hematopoietic stem cell therapy (before initiating Venetoclax or HMAs, Medications such as hydroxyurea were allowed to reduce the white-cell count to 1.0×109 per liter or less.) ; 4. bone marrow blast cell count (BM blast \> 5%) or IPSS-R score \> 3 (intermediate risk, high risk, very high risk); 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2; 6. complete case information could be obtained.
Exclusion criteria
1. patients who did not meet the inclusion criteria; 2. inability to obtain complete case information or to follow protocol steps or follow up on time; 3. other conditions considered by the investigators to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | After the first cycles treatment（Day1, Month2) | CR+mCR+PR+HI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IWG2023 Composite response rate | After the first cycles treatment（Day1, Month2 ) | CR+CR-L+CRh+CRequ |
| overall survival | through study completion, an average of 1 year | Refers to the time from the start of treatment to the patient's death or last follow-up. |
| Blood transfusion dependence | through study completion, an average of 1 year | Change in proportion of transfusion dependence from the start of treatment |
| adaverse event rate | Up to 1 years after the last subject enrolled. | Grade 3-4 adverse events |
Countries
China
Outcome results
None listed