Myelodysplastic syndrome
Conditions
Interventions
All trans retionic acid Capsules + Decitabine:Decitabine, intravenous infusion, 20mg/m2 per day, D1-5
All-trans retinoic acid 20mg BID (20mg tid for those weighing over 70KG), D1-28, starting from D1-14 in the fifth cycle, with each course lasting 28 days.
Placebo + Decitabine:Decitabine, administered via intravenous drip at a dose of 20 mg/m2 per day from D1 to D5, with each course lasting 28 days. Placebo is administered at 20 mg bid from D1 to D28 (2
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Study Population: Patients newly diagnosed with higher-risk MDS according to the IPSS-R scoring system, with bone marrow blasts >5%, and peripheral blood RARA expression higher than the 25th percentile of RARA expression in higher-risk MDS-negative patients. Participants must meet all of the following criteria to be enrolled: 1. Age >= 18 years; expected survival >= 3 months; 2. Within 30 days prior to enrollment, confirmed as newly diagnosed higher-risk MDS with bone marrow blasts >5% according to IPSS-R scoring system, after blood cell counts, bone marrow examination, and cytogenetic testing; 3. ECOG performance status 0-2; 4. Female participants of childbearing potential agree to use physician-approved contraception during treatment with decitabine and all-trans retinoic acid, within 1 month after the last dose of decitabine, and within 1 year after the last dose of retinoic acid; male participants with female partners who may become pregnant must agree to use physician-approved contraception throughout the study and avoid causing pregnancy in their partners during the study and for 2 months after the last dose of decitabine; 5. Adequate hepatic and renal function (creatinine <= 1.5*ULN, BUN <= 1.5*ULN, ALT <= 2*ULN, AST <= 2*ULN, total bilirubin <= 1.5*ULN); 6. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone hematopoietic stem cell transplantation in the past year, or those who have a recent plan to undergo hematopoietic stem cell transplantation; 2. Patients who have previously undergone transplantation or cytotoxic therapy for the treatment of MDS, including azacitidine, decitabine, and chemotherapy; 3. Patients who have received other therapeutic drugs (besides basic treatment) within 30 days prior to Day 1 of Cycle 1, including Compound Huangdai tablets, valproate sodium, anti-thymocyte globulin, arsenic trioxide, and retinoic acid therapy; 4. Participants who have participated in other clinical trials within 30 days; 5. Patients with a history of tumors and who have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia (CIN), "in situ" breast cancer, or prostatic intraepithelial neoplasia (PIN); or other localized malignant tumors that have a high probability of cure after surgical excision or radiotherapy; 6. Patients with uncorrected folate deficiency or vitamin B12 deficiency; 7. Patients with active viral or bacterial infections that cannot be controlled with appropriate anti-infective therapy; 8. Patients with known positive serological response for HIV; 9. Patients with mental disorders or other conditions that prevent cooperation with the study treatments and monitoring requirements; 10. Patients with uncontrolled heart disease; 11. Bone marrow aspiration; 12. Bone marrow fibrosis Grade 2-3; 13. Patients known to be allergic to decitabine, retinoic acid, or other investigational drugs; 14. Other conditions that the investigator believes make the patient unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Duration of response;Time to achieve best response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate;Overall response rate;Cytogenetic response;Progression-free survival;Leukemia transformation time;Time to response; | — |
Countries
China
Contacts
Public ContactHongyan Tong
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed