Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To explore the efficacy of venetoclax combined with azacytidine in Myelodysplastic / myeloproliferative neoplasms（MDS/MPN）, so as to improve the overall survival and treatment status of MDS/MPN patients.
At present, there is no standardized treatment strategy for MDS/MPN. The purpose of our study is to explore the efficacy of venetoclax combined with azacytidine in the treatment of MDS/MPN, so as to improve the overall survival and treatment status of patients with MDS/MPN. After the participants were treated with four cycles of venetoclax combined with azacytidine, the efficacy was evaluated according to the 2015 adult MDS/MPN response criteria to determine the disease status. Participants with disease progression and intolerance withdrew from the study during treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment regime | Experimental | On day 1 of each cycle, decitabine 75 mg/m2 will be given subcutaneously, and will continue for 5 days. Simultaneously the patient will start out with Venetoclax 100mg and progress to 400mg until the 14 day cycle is finished. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venetoclax combined with azacitidine | Drug | On day 1 of each cycle, decitabine 75 mg/m2 will be given subcutaneously, and will continue for 5 days. Simultaneously the patient will start out with Venetoclax 100mg and progress to 400mg until the 14 day cycle is finished. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR (equals the rates of complete remission [CR]+partial remission [PR]+complete cytogenetic remission [CCyR]+marrow response [MR[+clinical benefit [CB] )of venetoclax in combination with azacitidine.
| Study start date to study end date, or death, whichever comes first, up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate |
|
Not provided
Inclusion Criteria:
Male or female, Age (years) >= 18；
Patients newly diagnosed or previously treated with MDS/MPNs (CMML, MDS/MPN-U, aCML) according to 2016 WHO diagnostic criteria:
Initial diagnosis: CMML: CPSS-mol intermediate risk 2 and above; aCML; MDS/MPN-U.
Previous treatment: HMA treatment failed.
Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ;
Liver function: Total bilirubin ≤3 upper limit of normal (ULN); aspartate aminotransferase (AST) ≤3 ULN; alanine aminotransferase (ALT)≤3 ULN；
Renal function#Ccr ≥30 ml/min;
Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Suning Chen, Professor | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology | Suzhou | Jiangsu | 215000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Study start date to study end date, or death, whichever comes first, up to 4 years |
| Complete remission rate of bone marrow morphology | Presence of all marrow criteria necessary for CR without normalization of peripheral blood indices as presented above. | Study start date to study end date, or death, whichever comes first, up to 4 years |
| Hematology improvement (HI) rate | Percentages of participants with HI (erythroid/platelet/neutrophil responses)
| Study start date to study end date, or death, whichever comes first, up to 4 years |
| Complete cytogenetic remission rate | Resolution of previously present chromosomal abnormality (known to be associated with myelodysplastic, syndrome myeloproliferative neoplasms, or MDS/MPN), as seen on classic karyotyping with minimal of 20 metaphases or FISH. | Study start date to study end date, or death, whichever comes first, up to 4 years |
| Incidence of severe infection (≥grade 3 ) | Assessed using CTCAE 5 | Study start date to study end date, or death, whichever comes first, up to 4 years |
| Spleen response rate | Either a minimum 50% reduction in palpable splenomegaly of a spleen that is at least 10 cm at baseline or a spleen that is palpable at more than 5 cm at baseline becomes not palpable. | Study start date to study end date, or death, whichever comes first, up to 4 years |
| Symptom response rate | Improvement in symptoms as noted by decrease of ≥50% as per the MPN-SAF TSS scoring<20 were not considered eligible for measuring clinical benefit. | Study start date to study end date, or death, whichever comes first, up to 4 years |
| ID | Term |
|---|---|
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided