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1.
Biol Blood Marrow Transplant ; 26(6): 1043-1049, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32305359

RESUMO

The coronavirus-19 (COVID-19) pandemic poses a significant risk to patients undergoing hematopoietic stem cell transplantation (HCT) or cellular therapy. The American Society for Transplantation and Cellular Therapy Pharmacy Special Interest Group Steering Committee aims to provide pharmacy practice management recommendations for how to transition clinical HCT or cellular therapy pharmacy services using telemedicine capabilities in the inpatient and outpatient settings to maintain an equivalent level of clinical practice while minimizing viral spread in a high-risk, immunocompromised population. In addition, the Steering Committee offers clinical management recommendations for COVID-19 in HCT and cellular therapy recipients based on the rapidly developing literature. As the therapeutic and supportive care interventions for COVID-19 expand, collaboration with clinical pharmacy providers is critical to ensure safe administration in HCT recipients. Attention to drug-drug interactions (DDIs) and toxicity, particularly QTc prolongation, warrants close cardiac monitoring and potential cessation of concomitant QTc-prolonging agents. Expanded indications for hydroxychloroquine and tocilizumab have already caused stress on the usual supply chain. Detailed prescribing algorithms, decision pathways, and specific patient population stock may be necessary. The COVID-19 pandemic has challenged all members of the healthcare team, and we must continue to remain vigilant in providing pharmacy clinical services to one of the most high-risk patient populations while also remaining committed to providing compassionate and safe care for patients undergoing HCT and cellular therapies.


Assuntos
Betacoronavirus/efeitos dos fármacos , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Gerenciamento Clínico , Transplante de Células-Tronco Hematopoéticas , Pandemias , Serviço de Farmácia Hospitalar/organização & administração , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Betacoronavirus/patogenicidade , COVID-19 , Terapia Baseada em Transplante de Células e Tecidos/métodos , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/genética , Humanos , Hidroxicloroquina/uso terapêutico , Imunização Passiva , Pacientes Internados , Pacientes Ambulatoriais , Segurança do Paciente , Pneumonia Viral/diagnóstico , Pneumonia Viral/genética , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/estatística & dados numéricos , Opinião Pública , SARS-CoV-2 , Sociedades Médicas , Telemedicina/métodos , Estados Unidos/epidemiologia , Tratamento Farmacológico da COVID-19 , Soroterapia para COVID-19
2.
Am J Hematol ; 95(9): 1006-1014, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32390196

RESUMO

For patients with high risk myeloid disease, allogeneic hematopoietic cell transplantation (HCT) is the only potentially curative therapy. Unfortunately, many of these patients relapse after HCT and have a limited survival. The recent approval of venetoclax, an orally bioavailable BCL-2 inhibitor, resulted in significant responses in treatment naïve acute myeloid leukemia (AML), and off-label use in the relapsed/refractory setting is increasing. We report the outcomes of 21 patients who underwent allogeneic HCT for myeloid disease, relapsed with AML, and were treated with venetoclax. Several patients had poor risk features including antecedent hematologic malignancy (6/21), complex karyotype (6/21), and TP53 mutations (5/21). The median age was 64.5 years and time from HCT to relapse was 5.7 months (range: 0.9 to 44.9 months). Of the 19 patients who were assessed for response, there were meaningful treatment responses seen in eight patients: five CR, three CRi, zero PR, for an ORR of 42.1%. Treatment effect was seen in six additional patients, including four in the morphologic leukemia-free state. Nine patients maintained their response for ≥3 months and eight were receiving therapy at data cut. Post-HCT AML relapse has an exceedingly poor outcome, and venetoclax-based therapy is a potent therapy option that should be studied prospectively in this setting.


Assuntos
Compostos Bicíclicos Heterocíclicos com Pontes/administração & dosagem , Transplante de Células-Tronco Hematopoéticas , Leucemia Mieloide Aguda , Terapia de Salvação , Sulfonamidas/administração & dosagem , Adulto , Idoso , Aloenxertos , Intervalo Livre de Doença , Feminino , Humanos , Leucemia Mieloide Aguda/mortalidade , Leucemia Mieloide Aguda/terapia , Masculino , Pessoa de Meia-Idade , Taxa de Sobrevida
3.
Transpl Infect Dis ; 22(1): e13222, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31782875

RESUMO

BACKGROUND: Haploidentical bone marrow transplant (haplo-BMT) offers near universal donor availability as a curative modality for individuals with severe sickle cell disease (SCD). However, the required intense immunodepletion is associated with increased infectious complications. A paucity of data exists on immune reconstitution following haplo-BMT for SCD. METHODS: A multi-institution learning collaborative was developed in the context of a phase II clinical trial of a non-myeloablative, related haplo-BMT with post-transplant cyclophosphamide for SCD. We report results from a cohort of 23 patients for whom immune reconstitution data up to one year were available. RESULTS: Median age was 14.8 years. Out of 23, 18 participants received pre-conditioning with azathioprine, hydroxyurea, and hypertransfusions. 70% (16/23) of participants had multiple indications for haplo-BMT. We observed excellent immune reconstitution of CD4, CD8, CD19, and CD56 cellular subsets by 6 months post transplant. Engraftment rate and event-free survival in this cohort were 100% and 96%, respectively. 70% (16/23) of patients had at least one viral reactivation or infection, including CMV 35% (8/23), HHV-6 22% (5/23), and polyoma virus 17% (4/23), with no cases of post-transplant lymphoproliferative disease. CONCLUSION: Further prospective studies are needed to better characterize immune reconstitution and the immunologic basis for increased viral reactivation following haplo-BMT with post-transplant cyclophosphamide for SCD.


Assuntos
Anemia Falciforme/complicações , Transplante de Medula Óssea/efeitos adversos , Ciclofosfamida/administração & dosagem , Reconstituição Imune , Imunossupressores/administração & dosagem , Ativação Viral , Adolescente , Adulto , Criança , Ensaios Clínicos Fase II como Assunto , Intervalo Livre de Doença , Doença Enxerto-Hospedeiro , Humanos , Estudos Prospectivos , Condicionamento Pré-Transplante/efeitos adversos , Transplante Haploidêntico/efeitos adversos , Adulto Jovem
4.
Bone Marrow Transplant ; 55(6): 1137-1146, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-31992845

RESUMO

Modern combinations of therapies for multiple myeloma have led to improvement in survival outcomes with near 100% overall response rate and 25% complete response rates, particularly with autologous hematopoietic cell transplant (AHCT). Minimal residual disease (MRD) assessment with multiparameter flow cytometry is a valid prognostic biomarker for progression-free survival (PFS) and overall survival (OS). However, few data exist regarding whether MRD positivity or negativity will meaningfully influence treatment decisions. We evaluated 433 patients who received induction therapy, followed by AHCT. Participants had MRD assessment by multiparameter flow cytometry before and at days +100 and +365 following AHCT. They also received either lenalidomide, bortezomib, or no maintenance therapy following AHCT. Maintenance treatment with lenalidomide improved MRD negativity at day +365 compared to bortezomib (92.9% vs 41.6%, p = 0.01), or no maintenance therapy (92.9% vs 24.4%, p = 0.012). The median PFS for patients who were MRD negative at day + 365 was 42 vs 17.5 months (p < 0.001) and median OS was 80.6 vs 59 months (p = 0.02). Maintenance therapy following AHCT for multiple myeloma improves the depth of response as assessed by MRD.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Mieloma Múltiplo , Bortezomib , Intervalo Livre de Doença , Humanos , Lenalidomida/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Neoplasia Residual , Resultado do Tratamento
5.
Clin Hematol Int ; 1(2): 94-100, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34595416

RESUMO

Patients with high-risk myeloid neoplasms, including myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), are offered allogeneic hematopoietic cell transplantation (alloHCT) to improve the likelihood of long-term disease control. More than 50% of patients with high-risk disease will relapse after HCT and face a poor prognosis with shortened survival. The recent development of targeted therapies and effective, low-intensity treatment strategies will likely improve the outcomes of these patients. In MDS, hypomethylating agents (HMAs) are the mainstay of salvage therapy but new treatments with APR-246 and luspatercept demonstrate excellent results in phase 1 and phase 3 clinical studies, respectively. In AML, new directed agents in the relapsed/refractory setting include gilteritinib (FLT3-ITD/-TKD), ivosidenib (IDH1), and enasidenib (IDH2). In patients without targetable mutations, HMAs may be used, and early data with venetoclax-based regimens are encouraging.

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