AACR 2020: Ibtinib and Litoxi monotherapy follicle lymphoma Phase III Research Launch (PERSPECTIVE Study)

research background
For elderly or patients with fissyllosic lymphoma (FL), the first-line chemo-free (no chemotherapy) treatment options are very limitedAt present, rituximatomaishasis has been used as a single drug treatment for patients in old age, infirmity or low tumor load in clinical first-line treatmentIbtinib is a Bruton tyrosine kinase (BTK) inhibitor that has been approved in the United States for the treatment of a variety of B-cell malignanciesrecently, a Phase II study evaluated the efficacy of ibtinib (once a day) in combination with lytoxaine (1 intravenous infusion per week, four times in a row)Patients receive continuous ibtinib treatment until disease progression or unacceptable toxicity occursDuring the 34 months of median follow-up, the total mitigation rate was 85% and the total mitigation rate was 40%At 30 months of median follow-up, patients had 67% and 97% of total survival (OS) rates, respectivelyBased on the above results, the researchers further evaluated the efficacy of ibtinib-litoxim combination therapy in the Phase III PERSPECTIVE studyThe two basic objectives of the study were: (1) comparing PFS in ibtinib-litoxim and placebo-litoximthe therapy;Research MethodologyPERSPECTIVE Study is an ongoing multicenter, randomized, double-blind, placebo-controlled Phase III study that will recruit approximately 440 previously untreated FL patientsPatients included in the study met at least one GELF standard, aged between 70 or between 60 and 69, and had a combination of the following: creatine removal rate of 30-59 mL/min or ECOG physical status score 2Exclude patients who have previously received FL-related treatment or have evidence of central nervous system (CNS) suffering/transformational lymphomain the first part of the trial, eligible patients were randomly divided into two groups: patients in group A received ibtinib (once a day, orally) combination of lyutoxim, and patients in group B received oral placebo combined lytoxaine therapyBoth groups of patients were treated with rituximatoxadone once a week for 4 weeks, after which they were treated with rituximatoxthe second part of thetrial will further assess the prognosis of patients in Group A who have been treated with ibtinib for at least two yearsThis part of the patient will again be randomly divided into two groups: patients in the treatment group will continue to receive oral ibtinib treatment once a day, and patients in the control group will be replaced with a placebothe main endpoint of both parts of the test is PFSThe study is currently recruiting patients in the United States, Europe and the Asia-Pacific regionSource:!/9045/presentation/10730MedSci Source: MedSci Original