A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)
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|ClinicalTrials.gov Identifier: NCT01882803|
Recruitment Status : Active, not recruiting
First Posted : June 20, 2013
Results First Posted : November 20, 2018
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Indolent Non-Hodgkin Lymphoma||Drug: Duvelisib||Phase 2|
This is an open-label, single arm safety and efficacy study of duvelisib administered orally to subjects who have been diagnosed with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma) whose disease is refractory to rituximab and to either chemotherapy or RIT.
Approximately 120 subjects will receive 25 mg duvelisib BID over the course of 28-day treatment cycles for up to 13 cycles.
After completing 13 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 13 cycles, subjects must have evidence of response (CR or PR) according to the IWG criteria1 by the end of Cycle 13.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||October 20, 2021|
Other Name: Copiktra, IPI-145
- Overall Response Rate (ORR) in All Subjects During Treatment With Duvelisib Based on Standard Response. [ Time Frame: Every 8-16 weeks while on treatment with duvelisib; an expected average on-treatment duration of response follow-up of 24 months ]Summary of Best Overall Response and Overall Response Rate per IRC Assessment (FAS)
- Number of Subjects With Treatment- Emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values [ Time Frame: Every 2-8 weeks; up to 30 days after the last dose of duvelisib. ]Treatment-Emergent Adverse Events Occurring in ≥ 10% Subjects, by SOC and PT (FAS)
- Duration of Response [ Time Frame: Every 8-16 weeks; for an average duration of response follow-up of 24 months ]Duration of Response per IRC Full Analysis Set
- Progression-free Survival [ Time Frame: Every 8-16 weeks; for an average response / progression follow-up of 24 months ]Progression Free Survival per IRC Full Analysis Set
- Overall Survival [ Time Frame: Every 16 weeks; for an average survival follow-up of 24 months ]Overall Survival Full Analysis Set
- PK Plasma Concentrations of Duvelisib and Its Metabolite(s) [ Time Frame: Every 4 weeks for 12 weeks ]Pharmacokinetics - duvelisib concentration (ng/mL) Full Analysis Set
- Time to Response (TTR) [ Time Frame: First dose to first documentation of complete or partial response ]Time to Response per IRC Full Analysis Set
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): NCT01882803
|Study Chair:||Hagop Youssoufian, MD||Verastem, Inc.|