Authors: Gambacorti Passerini C, Farina F, Stasia A, Redaelli S, Ceccon M, Mologni L, Messa C, Guerra L, Giudici G, Sala E, Mussolin L, Deeren D, King MH, Steurer M, Ordemann R, Cohen AM, Grube M, Bernard L, Chiriano G, Antolini L, Piazza R
: Prospective compassionate-use named-patient protocol with single-agent crizotinib in ALK+ non-Hodgkin lymphoma (NHL) patients. Compassionate use was carried out under the indication from NCT00932893, building on an initial observation of
rapid efficacy in two patients.
Eligibility: Refractory or relapsed ALK+ NHL after at least one prior line of chemotherapy.
Study Treatment: Crizotinib 250 mg twice daily until disease progression.
Results: 11 patients were treated. Overall response rate = 90.9% (10 of 11 patients); 2-yr overall survival rate = 72.7%; 2-yr progression free survival rate = 63.7% (latest follow up October 2013).
Resistance mutations: Peripheral blood samples from two ALCL patients at pre-treatment and at relapse were tested for mutations in the kinase domain of NPM/ALK. ALK Q1064R was identified in one patient's sample at relapse, and this mutation was not present in the pre-treatment sample. ALK I117N + M1328I was identified in a second patient.