Phase 2 Study of Intermittent Dosing Schedules of Duvelisib in iNHL
Research type
Research Study
Full title
A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects with Indolent Non-Hodgkin Lymphoma (iNHL)
IRAS ID
270261
Contact name
Charlotte Pai
Contact email
Eudract number
2019-001381-14
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Not Applicable, Not Applicable
Duration of Study in the UK
4 years, 4 months, 27 days
Research summary
Indolent NHL (iNHL), which includes follicular lymphoma (FL), small lymphocytic leukemia (SLL) and marginal zone B-cell lymphoma, remains largely incurable, often requiring multiple lines of treatment after failure to anti-CD20 based chemotherapy. Duvelisib, a dual PI3K-δ and PI3K-γ inhibitor, is approved by the FDA for the treatment of adults with relapsed or refractory (R/R) SLL and FL after ≥ 2 prior systemic therapies as it was shown to be efficacious, with a favorable risk-benefit profile. TEMPO is a randomized, open-label, phase 2 study that will evaluate whether duvelisib efficacy at the approved 25 mg twice daily (BID) dose can be achieved and maintained with an acceptable or improved safety in adults with R/R iNHL in whom ≥ 1 line of prior therapy has failed profile by the inclusion of prespecified 2-week drug holidays. A total of 102 patients are planned to be enrolled. Patients will be randomized 1:1 to 2 arms. In arm 1, patients will receive duvelisib 25 mg BID for one 10-week (W) cycle followed by 25 mg BID on W3 and W4 of each subsequent 4-week cycle. In arm 2, patients will receive duvelisib 25 mg BID on W1, W2, W5, W6, W9, and W10 of one 10-week cycle and then on W3 and W4 of each subsequent 4-week cycle. Patients will be treated until disease progression, unacceptable toxicity, or withdrawal. The study has a 2-stage design. In stage 1, 15 patients will be enrolled in each arm, with response assessment after ≥ 3 cycles. If there are fewer than 6 partial or complete responses, consideration may be given to terminating the arm. Otherwise, in stage 2, 36 additional patients will be enrolled, for a total of 51 per arm. Approximately 50 sites will participate across 8 countries (USA, Germany, Italy, UK, Poland, Russia, Czech Republic, Korea).
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0662
Date of REC Opinion
15 Jan 2020
REC opinion
Further Information Favourable Opinion