Sobre o Departamento

Sobre o Departamento
Departamento de Hematologia, Hemoterapia e Terapia Celular (DHHTC) da AMRIGS foi fundado em 1993 e homologado em 24/06/2014. Seu objetivo é o de congregar os associados da AMRIGS especialistas em Hematologia, Hemoterapia e Terapia Celular. Também representa no estado do RS estes especialistas em suas áreas de atuação.
03/08/2017

NEJM: Midostaurin para LMA FLT3+

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BACKGROUND

Patients with acute myeloid leukemia (AML) and a FLT3 mutation have poor outcomes. We conducted a phase 3 trial to determine whether the addition of midostaurin — an oral multitargeted kinase inhibitor that is active in patients with a FLT3 mutation — to standard chemotherapy would prolong overall survival in this population.

 

METHODS

We screened 3277 patients, 18 to 59 years of age, who had newly diagnosed AML for FLT3 mutations. Patients were randomly assigned to receive standard chemotherapy (induction therapy with daunorubicin and cytarabine and consolidation therapy with high-dose cytarabine) plus either midostaurin or placebo; those who were in remission after consolidation therapy entered a maintenance phase in which they received either midostaurin or placebo. Randomization was stratified according to subtype of FLT3 mutation: point mutation in the tyrosine kinase domain (TKD) or internal tandem duplication (ITD) mutation with either a high ratio (>0.7) or a low ratio (0.05 to 0.7) of mutant to wild-type alleles (ITD [high] and ITD [low], respectively). Allogeneic transplantation was allowed. The primary end point was overall survival.

 

RESULTS

A total of 717 patients underwent randomization; 360 were assigned to the midostaurin group, and 357 to the placebo group. The FLT3subtype was ITD (high) in 214 patients, ITD (low) in 341 patients, and TKD in 162 patients. The treatment groups were well balanced with respect to age, race, FLT3 subtype, cytogenetic risk, and blood counts but not with respect to sex (51.7% in the midostaurin group vs. 59.4% in the placebo group were women, P=0.04). Overall survival was significantly longer in the midostaurin group than in the placebo group (hazard ratio for death, 0.78; one-sided P=0.009), as was event-free survival (hazard ratio for event or death, 0.78; one-sided P=0.002). In both the primary analysis and an analysis in which data for patients who underwent transplantation were censored, the benefit of midostaurin was consistent across all FLT3 subtypes. The rate of severe adverse events was similar in the two groups.

 

CONCLUSIONS

The addition of the multitargeted kinase inhibitor midostaurin to standard chemotherapy significantly prolonged overall and event-free survival among patients with AML and a FLT3 mutation. (Funded by the National Cancer Institute and Novartis; ClinicalTrials.gov number, NCT00651261.)


Atualização dos Estudos Clínicos
24/04/2017

Atualização dos Estudos Clínicos

ESTUDO INDICAÇÃO TRATAMENTO CLINICAL TRIALS MÉDICOS/LOCAIS
TOURMALINE
(C16021)
 
Manutenção 1º linha Mieloma Múltiplo
*Necessário FISH ao diagnóstico
 
Ixazomibe
X
Placebo
https://clinicaltrials.gov/ct2/show/NCT02312258?term=NCT02312258&rank=1 Dra. Cristiane Weber (HCPA)
Dra. Flávia Bianchin (CACON)
Dra. Mariza Schaan (HSL-PUCRS)
Dr. Marcelo Capra (HCMD)
BELLINI
(M14-031)
Mieloma Múltiplo que tenha recebido 1 a 3 linhas prévias  
Venetoclax + Bortezomibe + Dexametasona
X
Placebo + Bortezomibe + Dexametasona
 
https://clinicaltrials.gov/ct2/show/NCT02755597 Dra. Mariza Schaan (HSL-PUCRS)
 
MK3475-170 Linfoma Mediastinal de Grandes Células B Primário Recidivado ou Refratário
 
Pembrolizumabe https://www.clinicaltrials.gov/ct2/show/NCT02576990?term=mk3475-170&rank=1 Dra. Laura Fogliatto (HCPA)
 
MK3475-204  
Linfoma de Hodgkin clássico recidivado ou refratário
 
Pembrolizumabe x Brentuximabe https://www.clinicaltrials.gov/ct2/show/NCT02684292?term=mk3475-204&rank=1 Dra. Laura Fogliatto (HCPA)
 
CTP10-3.4  
Linfoma folicular, baixa carga tumoral 1º linha
 
CTP10 x Rituximabe https://www.clinicaltrials.gov/ct2/show/NCT02260804?term=ct-p10+3.4&rank=1 Dra. Laura Fogliatto (HCPA)
Dr Marcelo Capra (HCMD)
Dra. Flávia Bianchin (CACON)
MDS  
Anemia dependente de transfusão de hemácias e trombocitopenia devido a Síndromes Mielodisplásicasde baixo risco de acordo com o IPSS
 
Azacitidina x placebo https://www.clinicaltrials.gov/ct2/show/NCT01566695?term=AZA-MDS-003&rank=1 Dra. Laura Fogliatto (HCPA)
 
AML001  
Leucemia mielóide aguda em remissão completa
 
Azacitidina x placebo https://www.clinicaltrials.gov/ct2/show/NCT01757535?term=CC-486-AML-001&rank=1 Dra. Laura Fogliatto (HCPA)
 
CHRONOS-3 Linfoma folicular ou Linfoma Linfocítico de Células Pequenas ou Linfoma Linfoplasmocitoide ou Macroglobulinemia de Waldenstrom ou Linfoma de Zona Marginal recidivado após tratamento com rituximabe
 
Rituximabe + Copanlisibe x Rituximabe + Placebo https://clinicaltrials.gov/ct2/show/NCT02367040?term=chronos+3&rank=1 Dr Marcelo Capra (HCMD)
AML004 Leucemia Mielóide Aguda, avançado, paciente idoso, mutação da Isocitrato Desidrogenase 2
 
 
AG221 VO (inibidor seletivo e de primeira classe da atividade neomórfica da enzima mutante IDH2 e supressor  da produção de 2-HG) x tto convencional
 
https://clinicaltrials.gov/ct2/show/NCT02577406?term=AG+221+%28CC-90007%29&rank=1 Dra. Laura Fogliatto (HCPA)

Eltrombopag Added to Standard Immunosuppression for Aplastic Anemia
20/04/2017

Eltrombopag Added to Standard Immunosuppression for Aplastic Anemia

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BACKGROUND

Acquired aplastic anemia results from immune-mediated destruction of bone marrow. Immunosuppressive therapies are effective, but reduced numbers of residual stem cells may limit their efficacy. In patients with aplastic anemia that was refractory to immunosuppression, eltrombopag, a synthetic thrombopoietin-receptor agonist, led to clinically significant increases in blood counts in almost half the patients. We combined standard immunosuppressive therapy with eltrombopag in previously untreated patients with severe aplastic anemia.

 

METHODS

We enrolled 92 consecutive patients in a prospective phase 1–2 study of immunosuppressive therapy plus eltrombopag. The three consecutively enrolled cohorts differed with regard to the timing of initiation and the duration of the eltrombopag regimen (cohort 1 received eltrombopag from day 14 to 6 months, cohort 2 from day 14 to 3 months, and cohort 3 from day 1 to 6 months). The cohorts were analyzed separately. The primary outcome was complete hematologic response at 6 months. Secondary end points included overall response, survival, relapse, and clonal evolution to myeloid cancer.

 

RESULTS

The rate of complete response at 6 months was 33% in cohort 1, 26% in cohort 2, and 58% in cohort 3. The overall response rates at 6 months were 80%, 87%, and 94%, respectively. The complete and overall response rates in the combined cohorts were higher than in our historical cohort, in which the rate of complete response was 10% and the overall response rate was 66%. At a median follow-up of 2 years, the survival rate was 97%; one patient died during the study from a nonhematologic cause. Marked increases in bone marrow cellularity, CD34+ cell number, and frequency of early hematopoietic progenitors were noted. Rates of relapse and clonal evolution were similar to our historical experience. Severe rashes occurred in two patients, resulting in the early discontinuation of eltrombopag.

 

CONCLUSIONS

The addition of eltrombopag to immunosuppressive therapy was associated with markedly higher rates of hematologic response among patients with severe aplastic anemia than in a historical cohort. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT01623167.)


DHHTC

Departamento de Hematologia, Hemoterapia e Terapia Celular da AMRIGS

Av. Ipiranga 5311 - Porto Alegre/RS 
 
Fone: (51) 3014.2025 
Fax: (51) 3014.2029
 
relacoesassociativas@amrigs.org.br