Efficacy and Safety of HMAs Combined With Venetoclax Versus HMAs Alone in ND Int-and H-risk MDS or CMML

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Active, not recruiting

Conditions: CMML; MDS

Treatments: Drug: Venetoclax

Study type: Observational

Funder types: Other

Identifiers

NCT07318662

GDPH-2024-MDS-1.2

Details and patient eligibility

About

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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

224 participants in 2 patient groups

Venetoclax+HMAs

Description:

treatment group, the intervention is the use of Venetoclax(400mg，QD, 1-14d)

Treatment:

Drug: Venetoclax

Standard treatment(HMAs)

Description:

The control group，Azacitidine（75mg/m2 ，QD, sc，d1-d7）or Decitabine（15mg/m2, q8h-q12h, d1-d3 or 20mg/m2,qd, d1-d5)