A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma. (TEMPO)
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|ClinicalTrials.gov Identifier: NCT04038359|
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : October 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Indolent Non-hodgkin Lymphoma||Drug: Duvelisib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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) (TEMPO)|
|Actual Study Start Date :||September 24, 2019|
|Estimated Primary Completion Date :||May 30, 2022|
|Estimated Study Completion Date :||July 29, 2024|
Experimental: Duvelisib, Continuous and Intermittent Dosing
Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed two weeks on and two weeks off of each subsequent 4-week cycles.
Other Name: Copiktra, VS-0145
Experimental: Duvelisib, Intermittent Dosing
Duvelisib 25 mg BID dosed two weeks on and two weeks off.
Other Name: Copiktra, VS-0145
- ORR (Objective Response Rate) [ Time Frame: 36 months ]Proportion of subjects achieving a CR or PR will be estimated as per IWG Criteria.
- PFS (Progression Free Survival) [ Time Frame: 5 years ]From time of first dose of study intervention to PD or death.
- ORR (Objective Response Rate) [ Time Frame: ORR estimated at 6, 12, 18, and 24 months after first dose of study intervention. ]Proportion of subjects achieving a CR or PR will be estimated as per Lugano Criteria
- DOR (Duration of Response) [ Time Frame: 5 years ]From the time of first response to PD using KM methods.
- OS (Overall Survival) [ Time Frame: 5 years ]From time of first dose of study intervention to death.
- LNRR (Lymph Node Response Rate) [ Time Frame: 36 months ]LNRR will be calculated as the proportion of subjects achieving ≥ 50% decrease in the SPD of target lymph nodes.
- TTFR (Time To First Relapse) [ Time Frame: 36 months ]From the time of first dose of study intervention to time of first CR or PR.
- Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: 36 months ]From the time of screening to the end of Safety Follow-Up period of the study.
- Peak Plasma Concentration (Cmax) [ Time Frame: 36 months ]
- TTF (Time To Treatment Failure) [ Time Frame: 5 years ]From first dose of study intervention until discontinuation for any reason and will be summarized using KM methods.
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038359
|Contact: Gloria Patrickemail@example.com|
|Contact: Deborah Llyodfirstname.lastname@example.org|
|United States, Florida|
|Mid-Florida Cancer Centers||Recruiting|
|Orange City, Florida, United States, 32763|
|Contact: Kiran Penta 407-607-3018 email@example.com|
|Study Director:||Alena Zalutskaya, MD, PhD||Verastem, Inc.|