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Trial record 1 of 1 for:    NCT01882803
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A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Verastem, Inc. Identifier:
First received: May 31, 2013
Last updated: May 11, 2017
Last verified: June 2016
Phase 2 clinical trial to evaluate the safety and efficacy of IPI-145 as a monotherapy in subjects with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma) that is refractory to rituximab and to either chemotherapy or RIT.

Condition Intervention Phase
Indolent Non-Hodgkin Lymphoma
Drug: IPI-145 (duvelisib)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)

Resource links provided by NLM:

Further study details as provided by Verastem, Inc.:

Primary Outcome Measures:
  • Overall response rate (ORR) in all subjects during treatment with IPI-145 based on standard response. [ Time Frame: Every 8-16 weeks while on treatment with IPI-145; an expected average on-treatment duration of response follow-up of 24 months ]

Secondary Outcome Measures:
  • 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 IPI-145 ]
  • Duration of Response [ Time Frame: Every 8-16 weeks; for an average duration of response follow-up of 24 months ]
  • Progression-free survival [ Time Frame: Every 8-16 weeks; for an average response / progression follow-up of 24 months ]
  • Overall survival [ Time Frame: Every 16 weeks; for an average survival follow-up of 24 months ]
  • PK Plasma concentrations of IPI-145 and its metabolite(s) [ Time Frame: Every 4 weeks for 12 weeks ]
  • Time to response (TTR) [ Time Frame: First dose to first documentation of complete or partial response ]

Enrollment: 129
Study Start Date: May 2013
Estimated Study Completion Date: January 2018
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPI-145 Drug: IPI-145 (duvelisib)
PI3K Inhibitor

Detailed Description:

This is an open-label, single arm safety and efficacy study of IPI-145 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 IPI-145 BID over the course of 28-day treatment cycles for up to 13 cycles.

After completing 13 treatment cycles of IPI-145, subjects may continue to receive additional cycles of IPI-145 until disease progression or unacceptable toxicity. However, to receive additional cycles of IPI-145 beyond 13 cycles, subjects must have evidence of response (CR or PR) according to the IWG criteria1 by the end of Cycle 13.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01882803

  Show 67 Study Locations
Sponsors and Collaborators
Verastem, Inc.
Study Chair: Hagop Youssoufian, MD Verastem, Inc.
  More Information

Responsible Party: Verastem, Inc. Identifier: NCT01882803     History of Changes
Other Study ID Numbers: IPI-145-06
Study First Received: May 31, 2013
Last Updated: May 11, 2017

Keywords provided by Verastem, Inc.:
PI3K Inhibitor

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on May 25, 2017