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

Phase 3 Completed 86 enrolled The Lymphoma Academic Research Organisation Celgene Corporation · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2018-11-09
Primary completion: 2021-02-10
Completion: 2025-08-28

Publications

Dupuis J, Bachy E, Morschhauser F, Cartron G, Fukuhara N, Daguindau N, Casasnovas RO, Snauwaert S, Gressin R, Fox CP, d'Amore FA, Staber PB, Tournilhac O, Bouabdallah K, Thieblemont C, Andre M, Rai S, Ennishi D, Gkasiamis A, Nishio M, Fornecker LM, Delfau-Larue MH, Sako N, Mule S, de Leval L, Gaulard P, Tsukasaki K, Lemonnier F. Oral azacitidine compared with standard therapy in patients with relapsed or refractory follicular helper T-cell lymphoma (ORACLE): an open-label randomised, phase 3 study. Lancet Haematol. 2024 Jun;11(6):e406-e414. doi: 10.1016/S2352-3026(24)00102-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitidine	Other / unclassified	200 mg	Oral
Subject	Azacitidine	Other / unclassified	300 mg	Oral
Comparator	Bendamustine	Small molecule	120 mg/m2	Other
Comparator	Gemcitabine	Small molecule	1200 mg/m2	Other
Comparator	Romidepsin	Peptide	14 mg/m2	Other

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

Summary

Timeline

Publications

Drugs

Indications