myeloproliferative chronic myelomonocytic leukemia
Conditions
Interventions
Single arm:Standard-dose Decitabine (DEC) combined with Venetoclax (VEN)
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The Diagnosis of CMML was confirmed according to WHO (2022) diagnostic criteria within 30 days prior to enrollment, after a blood count, bone marrow examination, cytogenetic examination, and molecular genetic examination; 2. CMML-1 or CMML-2 with peripheral blood blasts =2% and/or bone marrow blasts =5%; 3. Classified as MP-CMML according to WHO (2022) typing criteria; 4. Patients aged 18 years or older (including 18 years); 5. Subjects have an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2 at screening; 6. Sound hepatic and renal function (creatinine =1.5 mg/dL, BUN =1.5 mg/dL, ALT =2×ULN,AST =2×ULN,TB =2×ULN); 7. Females of childbearing age are required to undergo a pregnancy test before receiving treatment. During treatment and within 3 months of the last dose, males and females of childbearing age must agree to use effective contraception ; 8. Subjects must sign an informed consent form;
Exclusion criteria
Exclusion criteria: 1. Patients aged <18 years or less; 2. Subjects with planned hematopoietic stem cell transplantation; 3. Have participated in other clinical trials within 30 days; 4. Patients who are pregnant and breastfeeding; 5. Have a history of a tumor and have received any treatment for that tumor within the past 3 years, except for superficial bladder cancer, basal or squamous epithelial cell carcinoma of the skin, cervical intraepithelial neoplasia (CIN), or prostate intraepithelial neoplasia (PIN); 6. Have an active viral or bacterial infection that is not controlled with appropriate anti-infective therapy; 7. Have a known positive serologic reaction to HIV or active hepatitis C virus; 8. Have a mental illness or other medical condition that prevents cooperation with treatment and surveillance; 9. Patients with bone marrow and/or peripheral blood blasts = 20%; 10. Bone marrow null aspirate, or bone marrow biopsy tissue section showing MF = grade 2; 11. Those with known hypersensitivity to any of the components of Decitabine and Venetoclax ; 12. Those have received treatment with Azacitidine, Decitabine, Venetoclax or other chemotherapeutic agents, or have undergone hematopoietic stem cell transplantation within the past year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response, CR/equivalent complete response, CR equivalent;Patial response;CR with incomplete count recovery, CRi;CR with partial hematologic recovery, CRh;Hematologic improvement, HI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytogenetic response;Minimal residual disease, MRD;Patient-reported outcomes, PROs;splenic response;Overall survival, OS;Event-free survival, EFS;Progression-free survival,PFS; | — |
Countries
China
Contacts
Public ContactZhijian Xiao
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical
Outcome results
None listed