| ObjectiveTo explore the clinical efficacy and safety of Blinatumomab in the treatment of refractory/relapsed(R/R)CD 19 positive acute leukemia.MethodsRetrospective analysis of the clinical data of 37 patients with R/R acute leukemia who received treatment with Blinatumomab in our center from August 2021 to March 2023.Calculate the efficacy and treatment related adverse reactions,and analyze the influencing factors on patient efficacy,overall survival(OS)time,and progression free survival(PFS)time.Results1.37 R/R patients,including 2 cases of acute transformation from chronic myeloid leukemia(CML),1 case of transformation from follicular lymphoma(FL)to B-cell lymphoma leukemia(B-ALL),1 case of transformation from myelodysplastic syndrome(MDS)to acute leukemia,and 2 cases of mixed phenotype acute leukemia(MPAL)(mixed with B and myeloid).One of 36 patients without undergoing bone puncture,who passed away on the third day of treatment due to gastrointestinal bleeding and multiple organ failure,were unable to evaluate the therapeutic effect.The complete response(CR)rate in one treatment cycle was 58.3%(21/36),with a negative conversion rate of 71.4%(15/21)for minimal residual lesions(MRD).2.37 R/R patients were treated with Blinatumomab in an unrelieved(NR)state.White blood cell(WBC)count of≥10 × 109/L before treatment is an adverse factor affecting the CR rate(P<0.05).The 1-year OS and PFS rates are respectively 50%and 18%.Univariate analysis showed that lactate dehydrogenase(LDH)≥250U/L before treatment was an adverse factor affecting the OS prognosis of patients treated with Blinatumomab(P<0.05).WBC≥10 × 109/L and LDH≥250U/L before treatment are adverse factors affecting PFS in patients treated with Blinatumomab(P<0.05),while allogeneic hematopoietic stem cell transplantation(allo-HSCT)after Blinatumomab is a good prognostic factor for patient OS(P=0.024).Multivariate analysis showed that before treatment,LDH≥ 250U/L(P=0.026),previous chemotherapy≥ 3 times(P=0.019),and the proportion of bone marrow Archaeocyte ≥ 50%(P=0.019)were independent adverse prognostic factors for patients with OS,while allo-HSCT(P=0.019)was independent adverse prognostic factors for patients with OS.3.A total of 34 out of 37 R/R patients were evaluable for treatment-related adverse reactions.Most patients have hematological adverse reactions,of which 25(73.5%)had adverse reactions ≥ grade 3.The incidence of cytokine release syndrome(CRS)was 73.5%(25/34),with a rate of 5.9%(2/34)for grade 3 CRS,11.8%(4/34)for grade 2 CRS,and 55.9%(19/34)for grade 1 CRS.The second most common non hematological adverse event was liver function injury(26.5%),in addition 5 cases(14.7%)experiencing gastrointestinal discomfort,3 cases(8.8%)experiencing hypertension,1 patient suffering from conjunctivitis,and 1 patient suffering from rash.Four patients(11.8%)had neurological symptoms,mostly manifested as headache,dizziness,peripheral neuropathy,facial and limb sensory abnormalities.The above drug related adverse reactions were classified as<3 according to the CTCAE 5.0 standard.Conclusion1.CD3-CD19 Bispecific T Cell Adaptor(BiTE)Blinatumomab is effective as a salvage treatment for R/R acute leukemia patients with CD 19 positivity.The OS of patients with LDH≥ 250U/L before treatment,previous chemotherapy≥ 3 times,and the proportion of bone marrow archaeocyte≥ 50%before treatment was significantly shortened,while allo-HSCT significantly prolonged the OS of patients.2.The adverse reactions that occur in the application of Blinatumomab in R/R patients are controllable,with short bone marrow suppression time,rare severe CRS and neurological toxicity,and treatment-related adverse reactions that can be improved after symptomatic treatment.ObjectiveTo explore the clinical efficacy of adding Blinatumomab to the induction therapy regimen for newly diagnosed B-ALL patients.MethodsCollect clinical data of 24 newly diagnosed B-ALL patients who received treatment with Blinatumomab in our center from August 2021 to March 2023.Summarize the efficacy and follow-up results of adding Blinatumomab to the induction treatment,and statistically analyze the incidence of infection and globulin decline in patients during the induction treatment period and the follow-up process。Results1.24 newly diagnosed B-ALL patients,15 males and 9 females,with a male to female ratio of 1.7:1 and a median age of 38 years(13-65 years).There were 8 patients with abnormal chromosomal karyotypes and 16 with normal karyotypes.14 patients found abnormalities in fusion genes,including 5 cases of BCR-ABL positivity,2 cases of E2A-PBX1(TCF3-PBX1)positivity,each case of MLL-AF4、TCF3-ZNF384 and EP300-ZNF384 positivity,each case of ZMYM2-FGFR1 and P2RY8-CRLF2 positivity,and 2 cases of IKZF deficiency.2.Twelve patients were treated with VP(Dex)+BiTE induction therapy,while the remaining 12 patients were treated with IVP(VDCP)+BiTE regimen.Five BCR-ABL positive patients and one FGFR1 rearrangement patient were treated with tyrosine kinase inhibitor(TKI).On the 14th day of monoclonal antibody treatment,the bone marrow assessment showed a complete response/complete response with incomplete hematological recovery(CR/Cri)rate of 95.8%(18 cases were CR,5 cases were CRi),and 23 patients(95.8%)achieved molecular response with negative MRD.Only one case is NR.During a median follow-up of 5.5(1-16)months,only 2 patients experienced late recurrence,all of whom were Philadelphia chromosome(Ph)negative B-ALL.3.12 patients who received VP(Dex)+BiTE regimen did not experience infection during induction therapy,while 5 out of 12 patients who received IVP(VDCP)+BiTE induction chemotherapy(20.8%)had concurrent infections during treatment,with a statistically significant difference(P=0.037),mainly bacteria and virus while fungal infections were rare.Before and after the use of BiTE,a decrease in globulin was also observed,with a median decrease of 9.45g/L(1.6-15.5g/L)and a median decrease time of 35 days(6-183 days).ConclusionThe combination of Blinatumomab and low-dose chemotherapy as an induction treatment regimen for newly diagnosed B-ALL patients is feasible,with a short time required to achieve remission and a deep degree of remission,which is worthy of validation in larger sample studies.ObjectiveTo explore the clinical efficacy of adding Blinatumomab to the induction therapy regimen for CD 19 positive mixed phenotype acute leukemia(MPAL)patients.MethodsCollect clinical data of 5 newly diagnosed MPAL patients who received treatment with Blinatumomab in our center.Summarize the efficacy,survival,and follow-up of Blinatumoma in the treatment of CD 19 positive MPAL.Results1.5 MPAL patients,of which 4 were male,with a median age of 47 years(21-60 years).There were 4 cases of B/M mixing and 1 case of B/T mixing.The chromosomes of all 5 patients were normal karyotypes.Multiple PCR or RNA seq detected fusion genes including MLL-AF4,ETV6-ABL1,MLL-PTD,and BCR-ABL.All 5 patients had genetic mutations related to the lymphoid and myeloid lineages.2.Among the 4 Ph negative MPAL patients,2 patients were treated with Ven+BiTE,which combined small molecule targeted drugs with immunotherapy,and 2 patients were treated with VA+BiTE.A Ph positive MPAL patient was treated with a third-generation TKI combined with Blinatumomab,which was a chemotherapy-free induction regimen.On the 14th day of using monoclonal antibodies,bone biopsy was performed and 3 patients achieved CR,of which 1 patient achieved MRD negative CR.During the interval of 28 days after induction therapy,bone biopsy was performed and all 5 patients achieved CR,with 3 patients achieving negative MRD response.During a median follow-up of 9(4-11)months,one patient experienced comprehensive recurrence during consolidation therapy,and one patient showed positive MRD conversion,but no bone marrow morphological recurrence occurred.By the end of follow-up,all patients were in CR status,and 2 patients had completed allo HSCT.ConclusionThe induction therapy of Blinatumomab for CD 19 positive MPAL patients is effective and worthy of prospective research validation. |
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