The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL
Official Title: Randomized Phase 3 Study Evaluating the Efficacy and the Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patient With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma
Study ID: NCT03593018
Brief Summary: This study evaluates the efficacy of Oral azacitidine versus single-agent Investigator's Choice Therapy in patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.
Detailed Description: Compared to B-cell Non-Hodgin Lymphoma (NHL), Angioimmunoblastic T-cell Lymphoma (AITL) is more resistant to conventional chemotherapy and is generally associated with an inferior outcome. In case of relapsed of refractory disease, survival durations are in the range of only a few months. Several agents have been evaluated in this setting in recent years: romidepsin, bendamustine or belinostat. The response rate with these agents rarely exceeds 30% and responses are usually of limited duration. Azacitidine is a nucleoside metabolic inhibitor indicated for the treatment of patients with various myelodysplastic syndrome (MDS) subtypes. In this case, azacitidine significantly increase the survival time compared to standard of care option. This response to azacitidine could be correlated to the existence of recurrent mutations and those mutations have also been described in AITL. The present protocol will use Azacitidine according to the same schedule than in MDS that is continuous treatment until progression or unacceptable toxicity.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital for Internal Medicine - University Hospital Graz, Graz, , Austria
Medical University of Vienna, Vienna, , Austria
A. Z. Sint-Jan Brugge-Oostende AV, Bruges, , Belgium
Cliniques Universitaires de Bruxelles - Hôpital Erasme, Bruxelles, , Belgium
CHU UCL Namur - Site Godinne, Yvoir, , Belgium
Aarhus University Hospital, Aarhus, , Denmark
Institut d'Hématologie de Basse Normandie, Caen, , France
CHU de Clermont-Ferrand - Hôpital Estaing, Clermont-Ferrand, , France
CHU Henri Mondor, Créteil, , France
CHU de Dijon, Dijon, , France
CHU de Grenoble, Grenoble, , France
CHRU de Lille, Lille, , France
CHU de Montpellier - Hôpital Saint-Eloi, Montpellier, , France
CHU de Nantes - Hôtel Dieu, Nantes, , France
Hôpital Necker, Paris, , France
Hôpital Saint-Louis, Paris, , France
CHU Haut-Lévèque - Centre François Magendie, Pessac, , France
CHU Lyon-Sud, Pierre-Bénite, , France
CH Annecy Genevois, Pringy, , France
CHU Pontchaillou, Rennes, , France
Centre Henri Becquerel, Rouen, , France
IUCT - Oncopole, Toulouse, , France
CHRU de Nancy - Hôpital de Brabois, Vandœuvre-lès-Nancy, , France
University College London Hospital, London, , United Kingdom
The Christie, Manchester, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Name: Jehan DUPUIS, MD
Affiliation: Henri Mondor University Hospital
Role: STUDY_CHAIR
Name: François LEMONNIER, MD
Affiliation: Henri Mondor University Hospital
Role: STUDY_CHAIR
Name: Kunihiro TSUKASAKI, MD
Affiliation: Saitama Medical University International Medical Center
Role: STUDY_CHAIR