This is a phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in subjects diagnosed with follicular lymphoma (FL) that is relapsed or refractory to either chemotherapy or radioimmunotherapy (RIT).
This is an open-label, single arm, multi-center clinical trial to evaluate the efficacy and safety of duvelisib administered to subjects who have been diagnosed with follicular lymphoma that is relapsed or refractory to either chemotherapy or RIT. Subjects (n=57) will receive 25 mg duvelisib twice daily (BID) over the course of 28-day treatment cycles for up to 12 cycles. After completing 12 treatment cycles of duvelisib, subjects may continue to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 12 cycles, subjects must have evidence of response (CR, PR or SD) by the end of Cycle 12.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Eligible subjects will be given duvelisib orally at a dose of 25 mg BID during each 28-day treatment cycle, for up to 12 cycles.
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGOverall Response Rate (ORR),
Defined as the best response of complete response/remission (CR) or partial response/remission (PR), according to the Cheson 2007 Criteria by Independent Review Committee (IRC)
Time frame: Within 7 days prior to initiating the next cycle of study treatment (i.e. Day -7 to Day 1) of Cycles 3, 5, 7, 9 (each cycle is 28 days) and at every fourth cycle thereafter (Cycle 13, 17, 21, etc.) up to the end of treatment, an average of 8 months.
ORR assessed by study sites according to the Cheson 2007 Criteria;
Time frame: Within 7 days prior to initiating the next cycle of study treatment (i.e. Day -7 to Day 1) of Cycles 3, 5, 7, 9 (each cycle is 28 days) and at every fourth cycle thereafter (Cycle 13, 17, 21, etc.) up to the end of treatment, an average of 8 months.
ORR assessed respectively by study sites and IRC, according to the Lugano 2014 Criteria;
Time frame: Within 7 days prior to initiating the next cycle of study treatment (i.e. Day -7 to Day 1) of Cycles 3, 5, 7, 9 (each cycle is 28 days) and at every fourth cycle thereafter (Cycle 13, 17, 21, etc.) up to the end of treatment, an average of 8 months.
Treatment-emergent adverse events (TEAEs), ECG measures, and changes in safety laboratory values;
Time frame: Every 2-8 weeks; up to 30 days after the last dose of duvelisib.
Duration of Response;
Time frame: Within 7 days prior to initiating the next cycle of study treatment (i.e. Day -7 to Day 1) of Cycles 3, 5, 7, 9 (each cycle is 28 days) and at every fourth cycle thereafter (Cycle 13, 17, 21, etc.) up to the end of treatment, an average of 8 months.
Progression-free survival;
Time frame: Every 12 weeks; for an average response / progression follow-up of 2 years.
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Overall survival;
Time frame: Every 3 months; for an average survival follow-up of 3 years.
Time to response;
Time frame: From the date of the first dose until the date of first documented complete response or partial response, assessed up to 2 years.
Maximum Plasma Concentration (ng/ml) for duvelisib and its metabolite IPI-656;
Time frame: Every 4 weeks for 12 weeks.
Area under the Curve (ng*h/ml) for duvelisib and its metabolite IPI-656;
Time frame: Every 4 weeks for 12 weeks
Elimination half life (h) for duvelisib and its metabolite IPI-656;
Time frame: Every 4 weeks for 12 weeks