The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care-COLCHICOVID study.

BACKGROUND: There is no strong evidence that any drug is beneficial either for the treatment of SARS-CoV-2 disease or for post-exposure prophylaxis. Therefore, clinical research is crucial to generate results and evaluate strategies against COVID-19. Primary care (PC) centers, the first level of care in the health system, are in a favorable position to carry out clinical trials (CD), as they work with a large volume of patients with varied profiles (from acute to chronic pathologies). During the COVID-19 pandemic, the need for hospital admission and mortality is higher in people > 60 years. Therefore, this is a target population to try to reduce the serious complications and lethality of COVID pneumonia and to avoid overloading the hospital system. Given the pharmacological properties of colchicine (anti-inflammatory and anti-fibrotic, possible inhibition of viral replication, and inhibitory effect on coagulation activation), early treatment with colchicine may reduce the rate of death and serious pulmonary complications from COVID-19 in vulnerable patients. METHODS: The COLCHICOVID study is a randomized, multicenter, controlled, open-label parallel group (2:1 ratio), phase III clinical trial to investigate the efficacy of early administration of colchicine in reducing the development of severe pulmonary complications associated with COVID-19 infection in patients over 60 years of age with at-risk comorbidities. DISCUSSION: This is a pragmatic clinical trial, adapted to usual clinical practice. The demonstration that early administration of colchicine has clinical effectiveness in reducing the complications of SARS-CoV-2 infection in a population highly susceptible may mitigate the health crisis and prevent the collapse of the health system in the successive waves of the coronavirus pandemic. In addition, colchicine is a well-known medicine, simple to use in the primary care setting and with a low cost for the health system. TRIAL REGISTRATION: ClinicalTrials.gov NCT04416334 . Registered on 4 June 2020. Protocol version: v 3.0, dated 22 September 2020.

Allogeneic stem cell transplantation using HLA-matched donors for acute myeloid leukemia with deletion 5q or monosomy 5: a study from the Acute Leukemia Working Party of the EBMT.

Deletion 5q or monosomy 5 (-5/5q-) in acute myeloid leukemia (AML) is a common high-risk feature that is referred to allogeneic stem cell transplantation. However, -5/5q- is frequently associated with other high-risk cytogenetic aberrations such as complex karyotype, monosomal karyotype, monosomy 7 (-7), or 17p abnormalities (abn (17p)), the significance of which is unknown. In order to address this question, we studied adult patients with AML harboring -5/5q- having their first allogeneic transplantation between 2000 and 2015. Five hundred and one patients with -5/5q- have been analyzed. Three hundred and thirty-eight patients (67%) were in first remission and 142 (28%) had an active disease at time of allogeneic transplantation. The 2-year probabilities of overall survival and leukemia-free survival were 27% and 20%, respectively. The 2-year probability of treatment-related mortality was 20%. We identified four different cytogenetic groups according to additional abnormalities with prognostic impact: -5/5q- without complex karyotype, monosomal karyotype or abn(17p), -5/5q- within a complex karyotype, -5/5q- within a monosomal karyotype and the combination of -5/5q- with abn(17p). In multivariate analysis, factors associated with worse overall survival and leukemia-free survival across the four groups were active disease, age, monosomal karyotype, and abn(17p). The presence of -5/5q- without monosomal karyotype or abn(17p) was associated with a significantly better survival rate while -5/5q- in conjunction with monosomal karyotype or abn(17p) translated into a worse outcome. The patients harboring the combination of -5/5q- with abn(17p) showed very limited benefit from allogeneic transplantation.

CD 30-positive transformed follicular lymphoma: two case reports and literature review.

AIMS: Here we report two cases of follicular lymphoma that transformed to CD30 positive diffuse large B cell lymphoma and review the literature on this topic. RESULTS: The first case represents an example of early transformation of conventional low-grade follicular lymphoma to CD30-positive large B cell lymphoma. Immunoglobulin (Ig)H and cytogenetic identity was demonstrated between both components. High-dose and auto-stem cell transplant (SCT) was applied and complete response was achieved. The second case represents an example of d'emblee transformation of intrafollicular neoplasia to CD30-positive large B cell lymphoma. Immunoglobulin K deleting element (IgKde) and cytogenetic identity between both phases was demonstrated. The patient was in partial response after four cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP). CONCLUSIONS: CD30 expression was found to be associated in these cases to the transformation event and could be considered a therapeutic target to add to conventional immunochemotherapeutic regimens, even in combination with auto-SCT. We suggest looking for CD30 expression in transformed follicular lymphoma cases.