Myelodysplastic syndrome
Conditions
Interventions
MDS-LB group:HLA-matched 4-5/6 site matched cord blood was transfused
Sponsors
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age 40-80 years, regardless of gender or race; (2) Not receiving immunosuppressive, demethylating, immunomodulatory therapy before receiving micro transplantation; (3) MDS confirmed by bone marrow morphology, histochemistry and immunophenotyping (WHO standard), and morphologically defined as conforming to MDS-LB: Bone Marrow Blasts < 5% and peripheral blood < 2% ; or diagnosed as hypoproliferative MDS (MDS-h) (4) After whole exome sequencing and verification, it was suggested that there were heterozygous genetic mutations in the FANC family germline; (5)Karnofsky score =60% , eastern cooperative oncology group (ECOG) physical status =2; (6) HLA-matched 4-5/6 loci matched cord blood, and blood type matched; (7) Cord blood carrying HLA-a02:01 or HLA-A24:02 was preferred; (8) Umbilical cord blood microtransplantation was performed : azacitidine (75mg / m2 qd, subcutaneously, d1-7) combined with lenalidomide (10mg qd, orally, d1-14). Umbilical cord blood was infused 24-48h after induction therapy [ TNC (1.5 ± 25 %) × 10^7/kg]. Repeated induction 1 + infusion of umbilical cord blood. After induction therapy, 3 courses of azacitidine (75 mg / m2 qd, subcutaneous administration, d1-7) were given to consolidate the treatment. Umbilical cord blood was infused within 24h-48h after single use.
Exclusion criteria
Exclusion criteria: (1) Patients with therapy-considered MDS, or with mutations in TP53, PTPN11, and CSF3R genes (2) Patients with secondary or higher surgery within the first 4 weeks (3) Patients currently diagnosed with malignancy other than MDS or undergoing treatment, the following exceptions were: had received treatment for a cure and had not developed a known active disease malignancy =3 years; Patients who had received adequate treatment, non-melanoma skin cancer or malignant freckle-like nevi without signs of disease (even if less than 3 years); Patients were adequately treated, carcinoma in situ without evidence of disease (even if less than 3 years) (4) Had a stroke or intracranial hemorrhage within the first 6 months; Presence of clinically significant cardiovascular disease: uncontrolled or symptomatic arrhythmias, congestive heart failure, myocardial infarction within 6 months before screening, any grade 3(moderate) or grade 4(severe) heart disease according to the New York Heart Association functional class method (NYHA) (5) Active human immunodeficiency virus (HIV) or active Hepatitis C virus (HCV, RNA polymerase chain reaction PCR positive) or active Hepatitis B virus (HBV, DNA PCR positive) infections (6) Life-threatening diseases other than MDS (7) Dependence on illicit drugs (8) Mental or cognitive impairment (9) Participation in other clinical trials 1 month before registration (10) Combining the use of immunomodulators, including immunosuppressants and immunoenhancers, before and after induction and consolidation therapy, as well as during follow-up; Combined whole-body or lymphoid irradiation (TBI or TLI).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone marrow routine;Bone marrow biopsy;Time-To-Progression, TTP;Disease-free-survival, DFS;Progression-free-survival, PFS;Overal survival, OS;Early mortality rate; | — |
Countries
China
Contacts
Public ContactWu Dijiong
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed