NCT03593018

Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients with Relapsed or Refractory AITL

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: The Lymphoma Academic Research Organisation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed Angioimmunoblastic T-Cell Lymphoma
• Refractory Angioimmunoblastic T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Oral azacitidine	Azacitidine tablets
DRUG	Romidepsin	Romidepsin injection
DRUG	Bendamustine	Bendamustine injection
DRUG	Gemcitabine	Gemcitabine injection

Timeline

• Start date: 2018-11-09
• Primary completion: 2021-02-10
• Completion: 2025-12-01
• First posted: 2018-07-19
• Last updated: 2025-03-05

Locations

27 sites across 5 countries: Austria, Belgium, Denmark, France, United Kingdom