Myelodysplastic Syndrome-Excess Blasts (MDS-EB)
Conditions
Interventions
Group 1:Retinoic acid tablets combined with dicitabine
Group 2:Dicitabine
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) At least 18 years of age; the expected survival time is longer than 3 months; 2) Diagnosed as MDS With Excess Blasts(EB) of the recognized WHO(2016) Revised classifications as determined by CBC, bone marrow assessment, and cytogenetics within 30 days of screening; 3) ECOG performance status 0-2; 4) Female subjects who may be pregnant agree to use physician-approved contraceptive methods during and within one month after the last dose of dicitabine and one year after the last dose of tretinoin.Male subjects whose female partners may be pregnant must agree to a physician-approved method of contraception throughout the study period and avoid female companionship throughout the study period and within two months after the last dose of dicitabine Pregnancy; 5) Adequate hepatic and renal function as following: (creatinine <= 1.5 * ULN, BUN <= 1.5 * ULN, ALT <=2 * ULN, AST <= 2 * ULN, total bilirubin <= 1.5 * ULN); 6) Sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1) Patients who have received hematopoietic stem cell transplantation (HSCT) in the past year; 2) Previous transplantation or cytotoxic therapy for MDS, including azacytidine, dicitabine and chemotherapy; 3) Within 30 days prior to the first day of cycle 1, other therapeutic drugs (except basic treatment) were given, including compound Huangdai tablets, sodium valproate, antithymocyte globulin arsenic trioxide and retinoic acid ; 4) Participated in other clinical trials within 30 days; 5) Has a prevoius malignancy history and accepted treatment for it within 3 years, except for superficial bladder cancer, basal cell carcinoma of the skin or squamous carcinoma of the skin, cervical intraepithelial carcinoma or intraepithelial carcinoma of prostate; or other local malignant tumors with high cure rate after surgical resection or radiotherapy; 6) Uncorrected folic acid deficiency or vitamin B12 deficiency; 7) Has active viral or bacterial infection, and has uncontrolled infection under anti-infection treatment; 8) Positive blood tests of AIDS; 9) Subject who has mental illness or other disease can't adhere to the study requirements; 10) Patients with uncontrolled heart disease; 11) Bone marrow dry tap; 12) Myelofibrosis grade 2-3; 13) Known patients with allergy to itacitabine, vitamin A acid or other research agents; 14) The researchers believe that there are other circumstances that are not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate by Independent review committee; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Bone marrow complete remission rate;Hematologic improvement rate;Cytogenetic reaction rate;Progression-free survival;Overall survival;Overall response rate by investigator;Response time;AML transformation time; | — |
Countries
China
Contacts
Public ContactHongyan Tong
Department of Hematology, The First Affiliated Hospital, Zhejiang University
Outcome results
None listed