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Spots Global Cancer Trial Database for Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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