ENTO + VCR in Adult Subjects with Non-Hodgkin Lymphoma
Research type
Research Study
Full title
A Phase 1b-2, Open-Label, Dose Escalation and Expansion Study Evaluating the Safety and Efficacy of Entospletinib (ENTO) combined with Vincristine (VCR) and VCR-based Combination Chemotherapy in Adult Subjects with Non-Hodgkin Lymphoma (NHL)
IRAS ID
189157
Contact name
Kim Linton
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2015-002731-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 6 months, 4 days
Research summary
Lymphoma accounts for 4% of all new cancer diagnoses and is the sixth most common cancer in the UK (2011). Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of Non-Hodgkin (NHL) lymphoma and is curable in ~60% of patients with standard first line chemotherapy. Treatment options are limited for patients with DLBCL that have failed to respond to treatment (refractory disease) or have recurred following treatment (relapsed disease).
This clinical study will evaluate the safety and efficacy of the study medication Entospletinib (ENTO) combined with Vincristine (VCR) and VCR-based combination chemotherapy in adult participants with NHL. The study will be conducted in two phases (dose escalation and dose expansion). The dose escalation phase will evaluate four different dose levels of the ENTO + VCR combination in participants with any subtype of relapsed/refractory NHL. The maximum tolerated dose determined from dose-escalation will be evaluated in the dose expansion phase, which will enrol patients with DLBCL only, including those with previously untreated disease and those with relapsed and/or refractory disease.
Potential participants will undergo eligibility screening prior to enrolling on the trial. Treatment on the dose escalation phase will be a combination of ENTO and VCR. Treatment on the dose expansion phase will be ENTO and VCR at the assigned dose level (relapsed and/or refractory DLBCL) or ENTO plus first line chemotherapy (RCHOP or DA-EPOCH-R) (previously untreated DLBCL). Treatment will last for a maximum of 6 cycles (each cycle lasts 21 – 28 days), unless disease progression occurs or any other exclusion criteria are met. After treatment, participants will be followed for safety for 30 days and for survival every ~3 months for up to 5 years.
Approximately 124 participants aged 18 years or older will be enrolled on the trial (34 on the dose escalation and 90 on the dose expansion phase).REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0948
Date of REC Opinion
25 Jan 2016
REC opinion
Further Information Favourable Opinion