A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)
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| ClinicalTrials.gov Identifier: NCT01882803 |
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Recruitment Status : Unknown
Verified March 2021 by SecuraBio.
Recruitment status was: Active, not recruiting
First Posted : June 20, 2013
Results First Posted : November 20, 2018
Last Update Posted : March 17, 2021
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| 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 |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Duvelisib |
Drug: Duvelisib
PI3K Inhibitor
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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects who have been diagnosed with indolent NHL that has progressed.
- Subjects must have exhibited lack of CR or PR or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT.
- Subjects must have rituximab-refractory disease, defined as lack of CR or PR or PD within 6 months of last dose.
- Measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension by CT, PET/CT or MRI.
- Adequate renal and hepatic function.
Exclusion Criteria:
- Candidate for potentially curative therapies in the opinion of the investigator.
- Previous treatment with a PI3K inhibitor or BTK inhibitor.
- Prior history of allogeneic hematopoietic stem cell transplant (HSCT).
- Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
- Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
- Symptomatic central nervous system (CNS) NHL.
- Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
- Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis C virus antibodies (HCV Ab) or hepatitis B surface antigen (HBsAg) or hepatitis B core antibodies (HBcAb)
- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug
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
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| Study Chair: | Hagop Youssoufian, MD | Verastem, Inc. |
| Responsible Party: | SecuraBio |
| ClinicalTrials.gov Identifier: | NCT01882803 |
| Other Study ID Numbers: |
IPI-145-06 |
| First Posted: | June 20, 2013 Key Record Dates |
| Results First Posted: | November 20, 2018 |
| Last Update Posted: | March 17, 2021 |
| Last Verified: | March 2021 |
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PI3K Inhibitor |
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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |