Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

Summary

This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.

Timeline

Start

2012-06-11

Primary completion

2015-06-30

Completion

2017-12-18

Outcome

Missed primary endpoint

registry analysis (superiority test); Alisertib vs Pralatrexate, or Romidepsin, or Gemcitabine; p = 0.038; Odds Ratio (OR) 0.60 (95% CI 0.33 to 1.08); NCT01482962 ↗

registry analysis (superiority test); Alisertib vs Pralatrexate, or Romidepsin, or Gemcitabine; p = 0.177; Hazard Ratio (HR) 0.87 (95% CI 0.637 to 1.178); NCT01482962 ↗

Publications

• O'Connor OA, Ozcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trumper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized Phase III Study of Alisertib or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. doi: 10.1200/JCO.18.00899. Epub 2019 Feb 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alisertib	Small molecule	50 mg	Oral
Comparator	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Comparator	Pralatrexate	Other / unclassified	30 mg/m2	Intravenous
Comparator	Romidepsin	Peptide	14 mg/m2	Intravenous

Indications