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A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882803
Recruitment Status : Active, not recruiting
First Posted : June 20, 2013
Results First Posted : November 20, 2018
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

Tracking Information
First Submitted Date  ICMJE May 31, 2013
First Posted Date  ICMJE June 20, 2013
Results First Submitted Date  ICMJE October 23, 2018
Results First Posted Date  ICMJE November 20, 2018
Last Update Posted Date May 15, 2020
Actual Study Start Date  ICMJE May 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
Objective 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 20 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
  • Number of drug-related (at least possibly) adverse events; Number of serious adverse events [ 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 ]
  • Plasma concentrations of IPI-145 and its metabolite(s) [ Time Frame: Every 4 weeks for 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)
Official Title  ICMJE A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)
Brief Summary Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Indolent Non-Hodgkin Lymphoma
Intervention  ICMJE Drug: Duvelisib
PI3K Inhibitor
Other Name: Copiktra, IPI-145
Study Arms  ICMJE Experimental: Duvelisib
Intervention: Drug: Duvelisib
Publications * Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Mayer J, Merli M, Lunin SD, Pettitt AR, Nagy Z, Tournilhac O, Abou-Nassar KE, Crump M, Jacobsen ED, de Vos S, Kelly VM, Shi W, Steelman L, Le N, Weaver DT, Lustgarten S, Wagner-Johnston ND, Zinzani PL. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019 Apr 10;37(11):912-922. doi: 10.1200/JCO.18.00915. Epub 2019 Feb 11. Erratum in: J Clin Oncol. 2019 Jun 1;37(16):1448.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 19, 2015)
129
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2013)
120
Estimated Study Completion Date  ICMJE October 20, 2021
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Belgium,   Bulgaria,   Canada,   Czechia,   France,   Georgia,   Hungary,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT01882803
Other Study ID Numbers  ICMJE IPI-145-06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Verastem, Inc.
Study Sponsor  ICMJE Verastem, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hagop Youssoufian, MD Verastem, Inc.
PRS Account Verastem, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP