A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid®) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: The EXPECT trial
Fitoussi O.,Service Donco hematologie |
Haioun C.,Unite Hemopathies Lymphoides |
Haioun C.,University Paris Est Creteil |
Thieblemont C.,Hospital Saint Louis |
And 8 more authors.
European Journal of Cancer | Year: 2013
This multicentre, single-arm, open-label phase 2 trial investigated the efficacy and safety of lenalidomide monotherapy in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). Methods Patients received oral lenalidomide 25 mg once daily on days 1-21 of each 28-day cycle for a maximum of 24 months, until disease progression or development of unacceptable adverse events (AEs). The primary end-point was efficacy; safety was evaluated as a secondary end-point. This study was registered with ClinicalTrials.gov, number NCT00655668. Findings A total of 54 patients with PTCL were treated. The overall response rate was 22% (12 of 54), including complete response (CR) or unconfirmed CR (CRu) in 11% of patients; 31% of patients with angioimmunoblastic T-cell lymphoma (AITL) responded (CR/CRu in 15% of patients). The median progression-free survival and median response duration were 2.5 and 3.6 months, respectively, in the intent-to-treat population, and 4.6 and 3.5 months, respectively, in patients with AITL. Thrombocytopenia and neutropenia were the most common grade 3 or 4 haematological AEs, in 11 (20%) and 8 (15%) patients, respectively. Overall, 19 patients (35%) experienced at least 1 AE leading to study dose interruption or reduction (commonly neutropenia or thrombocytopenia). Serious AEs were observed in 54% of patients and 12 patients died during the study; lymphoma progression (n = 6); and acute respiratory distress syndrome, dyspnea, lung infiltration, neutropenic sepsis, pneumonia and cerebral ischaemia (n = 1 each). Interpretation Lenalidomide exhibited single-agent activity in heavily pretreated patients with PTCL, particularly in patients with AITL. Future development is warranted in specific histologies, such as AITL, and in combination with chemotherapy or other agents considered active in PTCL. Funding Celgene Corporation. © 2013 Elsevier Ltd. All rights reserved. Source
Rubio M.-T.,Service dHematologie Clinique |
Charbonnier A.,Service dHematologie Clinique |
de Berranger E.,Service de pediatrie |
Gandemer V.,Rennes University Hospital Center |
And 11 more authors.
Pathologie Biologie | Year: 2013
In the attempt to harmonize clinical practices between different French transplantation centers, the French Society of Bone Marrow Transplantation and Cell Therapy (SFGM-TC) set up the third annual series of workshops which brought together practitioners from all member centers and took place in October 2012in Lille. Here we report our results and recommendations regarding vaccination post Hematopoietic Stem Cell Transplantation with practical focus on which vaccines to use and when and how to vaccinate? © 2013. Source
Delarue R.,Service dHematologie Adultes
Oncologie | Year: 2011
Rituximab is associated with late-onset neutropenia, which occurs after the end of therapy. This side effect was initially considered a rare phenomenon, but recent studies have suggested an incidence rate between 5 and 30%. Although its physiopathology is poorly understood, recent advances have suggested that production of large granular lymphocytes and/or disruption of B-cell homeostasis during B-cell recovery after rituximab therapy could explain the occurrence of neutropenia. This complication is not usually associated with life-threatening complications, and treatment is based on antibiotics and G-CSF, if indicated. Retreatment after the first episode of neutropenia is probably associated with an increased risk of relapse. Besides this complication, the use of rituximab alone or with chemotherapy is associated with an increased risk of neutropenia and infection during treatment. These infectious complications are usually benign, mostly within the ORL and bronchus tract. © 2011 Springer Verlag France. Source
Bay J.-O.,Estaing University Hospital Center |
Peffault de Latour R.,Service dHematologie Greffe de Moelle |
Bruno B.,Service dHematologie pediatrique |
Coiteux V.,Service des Maladies du Sang |
And 10 more authors.
Pathologie Biologie | Year: 2013
In the attempt to harmonize clinical practices between different French transplantation centers, the French Society of Bone Marrow Transplantation and Cell Therapy (SFGM-TC) set up the third annual series of workshops which brought together practitioners from all member centers and took place in October 2012 in Lille. Here the SFGM-TC addressed the issue of post-transplant CMV and EBV reactivation, and EBV-related Lymphoproliferative Disorders. © 2013. Source
Treatment of adult ALL with central nervous system involvement at diagnosis using autologous and allogeneic transplantation: A study from the Société Française de Greffe de Moelle et de Thérapie Cellulaire
Chantepie S.P.,Caen University Hospital Center |
Chantepie S.P.,University of Caen Lower Normandy |
Mohty M.,Nantes University Hospital Center |
Tabrizi R.,Bordeaux University Hospital Center |
And 6 more authors.
Bone Marrow Transplantation | Year: 2013
To assess the role of hematopoietic SCT (HSCT) in adult ALL patients with central nervous system involvement at diagnosis, we retrospectively analyzed 90 patients who underwent autologous HSCT (auto-HSCT group; n=27) or allogeneic HSCT (allo-HSCT group; n=63) and reported to the Société Française de Greffe de Moelle et de Thérapie Cellulaire registry between 1994 and 2008. At the time of transplantation, 67 patients (74%) were in first CR, 15 (17%) in CR≥2 and 8 (9%) with progressive disease. The 5-year probabilities of overall survival (OS) and disease-free survival (DFS) were 52% and 46% for the allo-HSCT and 37% and 33% for the auto-HSCT groups, respectively (P=NS). The TRM at 5 years was 29.8% for the allo-HSCT group and 3.7% for the auto-HSCT group. Using univariate analysis, a time for transplantation of <12 months, the remission status at transplantation, the use of high-dose TBI and the number of the transplant were all determined to be prognostic factors for improved DFS and OS probabilities. Using multivariate analysis, we demonstrated that both the use of high-dose TBI and the remission status had a favorable impact on OS. Although the DFS and OS were better in the allo-HSCT group, the differences were not statistically significant. © 2013 Macmillan Publishers Limited All rights reserved. Source