TAK-659 for DLBCL patients after 2 prior lines of chemotherapy
Research type
Research Study
Full title
Phase 2 Study of TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma After at Least 2 Prior Lines of Chemotherapy
IRAS ID
227102
Contact name
William Townsend
Contact email
Sponsor organisation
Millenium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
Eudract number
2016-003716-12
Clinicaltrials.gov Identifier
119 231, IND
Duration of Study in the UK
3 years, 4 months, 12 days
Research summary
This is an open-label, single-arm, multicentre phase 2 study of TAK-659 (the study medication) in patients with diffuse large B-cell lymphoma (DLBCL) (see below). The patient population will consist of DLBCL patients who are relapsed or refractory (unresponsive to medication) after at least two prior lines of chemotherapy. Eligible patients will also be ineligible for autologous stem cell transplant (ASCT, a treatment where the patient’s own stem cells are collected and then returned to replace stem cells damaged by high doses of chemotherapy) or be patients for whom ASCT has failed.
DLBCL is the most common type of non-Hodgkin lymphoma (NHL), representing about 30% of all NHL. It is estimated that approximately 10,000 new cases of NHL, including 5,000 new cases of DLBCL, are diagnosed annually just in the United Kingdom. DLBCL is a form of aggressive B-cell NHL that is invariably fatal without treatment.
It is expected that approximately 82 male and female patients aged 18 years or older will be enrolled in the study, in approximately 40 sites in North America and Europe. Once enrolled, patients will be administered TAK-659 orally on a continuous daily dosing schedule of 100 mg once per day in 28-day treatment cycles. After approximately 40 patients have been enrolled and have had the opportunity to receive at least two cycles of study treatment and have at least 1 post-treatment response evaluated, an interim analysis will assess futility, and the study may either stop for futility or continue as planned.
Patients taking TAK-659, including those who achieve a complete remission, may receive study medication until they experience disease progression or unacceptable toxicities. Patients will be followed for progression-free survival (PFS) (applies only for patients who discontinue study for reasons other than disease progression) and overall survival (OS) after their last dose of study medication.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0181
Date of REC Opinion
18 Jul 2017
REC opinion
Further Information Favourable Opinion