Phase 2 Study of Duvelisib in Patients with Peripheral T Cell Lymphoma
Research type
Research Study
Full title
A Multi-Center, Phase 2, Open-label, Parallel Cohort Study of Efficacy and Safety of Duvelisib in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
IRAS ID
269311
Contact name
Christopher Fox
Contact email
Sponsor organisation
Verastem Inc.
Eudract number
2019-001123-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
VS-0145 (IPI-145), Investigational Product Name: Duvelisib
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Peripheral T-cell Lymphoma (PTCL) is the largest type of T-cell lymphoma. T-cell lymphoma is a type of cancer where T-cells in the body become abnormal. T-cells are white blood cells that fight infection. The purpose of this research is to learn the effects and safety of duvelisib in participants with PTCL. Duvelisib is an investigational drug (a drug that is not approved for sale) designed to stop cancer growth by blocking PI3 kinase activity. PI3 kinase is an enzyme that is overproduced by some cancers and can fuel cancer growth. PI3 kinase activity is known to be increased in many blood cancers. Data from clinical studies with duvelisib have shown a reduction of blood cancers including chronic lymphocytic leukaemia (CLL), indolent non-Hodgkin’s lymphoma, and T cell lymphoma (cutaneous T cell lymphoma and Peripheral T cell Lymphoma (PTCL)) with an acceptable safety profile. Duvelisib has received approval in the United States for other types of cancer called CLL, small lymphocytic lymphoma, and follicular lymphoma in adults after at least 2 prior treatments.
This research will:
• Find the appropriate duvelisib dose level for the treatment of PTCL that has come back (relapsed) or that has not responded to standard treatment (refractory).
• Understand how well duvelisib is working in participants with relapsed or refractory PTCL who are receiving the appropriate duvelisib dose level (this is called efficacy).
• Characterise the tolerability and safety of duvelisib in participants with relapsed or refractory PTCL who are receiving the appropriate duvelisib dose level.
• Measure the amount of duvelisib and compounds related to duvelisib in your body at different times (this is called pharmacokinetics [PK]).This study will involve a total of 90-130 participants across approximately 45 sites throughout United States, Japan, Italy, Germany and possibly other regions and countries.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0388
Date of REC Opinion
7 Feb 2020
REC opinion
Further Information Favourable Opinion