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Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma (DYNAMO + R)

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ClinicalTrials.gov Identifier: NCT02204982
Recruitment Status : Terminated (Sponsor is focusing on studies which can enable registration of duvelisib)
First Posted : July 31, 2014
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

July 25, 2014
July 31, 2014
May 4, 2018
September 2014
December 2016   (Final data collection date for primary outcome measure)
Progression-Free Survival (PFS) [ Time Frame: Until disease progression, for up to 5 years from randomization ]
Same as current
Complete list of historical versions of study NCT02204982 on ClinicalTrials.gov Archive Site
  • Overall Response Rate (ORR) [ Time Frame: Until disease progression, for up to 5 years from randomization ]
  • Overall Survival (OS) [ Time Frame: Every 6 months for up to 7 years from randomization ]
  • Duration of Response (DOR) [ Time Frame: Until disease progression, for up to 5 years from randomization ]
  • Treatment- emergent adverse events (TEAEs) and changes in safety laboratory values [ Time Frame: 30 days from last dose ]
  • Plasma concentrations of IPI-145 and its metabolite(s) [ Time Frame: Every 4 weeks for 12 weeks ]
  • Overall Response Rate (ORR) [ Time Frame: Until disease progression, for up to 5 years from randomization ]
  • Overall Survival (OS) [ Time Frame: Every 6 months for up to 7 years from randomization ]
  • Duration of Response (DOR) [ Time Frame: Until disease progression, for up to 5 years from randomization ]
  • Safety [ Time Frame: 30 days from last dose ]
    Treatment- emergent adverse events (TEAEs) and changes in safety laboratory values
  • Plasma concentrations of IPI-145 and its metabolite(s) [ Time Frame: Every 4 weeks for 12 weeks ]
Not Provided
Not Provided
 
Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
A study to evaluate the safety and efficacy of IPI 145 administered in combination with rituximab vs placebo in combination with rituximab in patients with previously treated CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.

Study IPI-145-08 is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of IPI-145 in combination with rituximab vs placebo in combination with rituximab in subjects with previously treated CD20-positive follicular lymphoma.

Approximately 400 subjects will receive 25 mg of IPI-145 or placebo, orally BID for 28 day continuous cycles, in combination with 375 mg/m2 of Rituximab given once weekly for 4 weeks during Cycle 1 and then once on Day 1 of Cycles 4, 6, 8, and 10. Patients will remain on treatment for up to 27 cycles and may continue treatment if clinical benefit is observed.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Follicular Lymphoma
  • Drug: IPI-145 (duvelisib)
    IPI-145 (25 mg BID) administered orally in 28-day continuous treatment cycles
  • Drug: Placebo
    Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
  • Drug: Rituximab
    IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
    Other Names:
    • Rituxan
    • MabThera
  • Experimental: IPI-145 + Rituximab

    IPI-145 is administered orally and supplied as 5 mg and 25 mg formulated capsules.

    Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.

    Interventions:
    • Drug: IPI-145 (duvelisib)
    • Drug: Rituximab
  • Placebo Comparator: Placebo + Rituximab

    Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.

    Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.

    Interventions:
    • Drug: Placebo
    • Drug: Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
400
March 2017
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of CD20-positive FL:

    • Histology grades 1, 2 or 3a
    • Biopsy-confirmed histopathological diagnosis of FL. Biopsy specimen should be obtained ≤2 years prior to randomization, unless medically contraindicated
  • CD20 immunophenotyping performed ≤2 years prior to randomization
  • First or subsequent relapse following at least one induction therapy regimen containing rituximab in combination with an anthracycline or rituximab in combination with an alkylating agent
  • Patients in first relapse must be chemoresistant or intolerant to chemotherapy
  • No response or disease progression ≤ 24 months from start of last previous therapy
  • At least 1 measurable disease lesion >1.5 cm in at least one diameter by CT/CT-PET or magnetic resonance imaging (MRI) in an area of no prior radiation therapy, or in an area that was previously irradiated that has documented progression

Exclusion Criteria:

  • Clinical evidence of other indolent forms of lymphoma (e.g., marginal zone lymphoma [MZL], small lymphocytic lymphoma [SLL])
  • Transformation to a more aggressive subtype of lymphoma or grade 3b FL
  • Refractory to rituximab: defined as disease progression while receiving or within 6 months of completing either weekly rituximab induction therapy, or rituximab-based chemoimmunotherapy induction
  • Intolerance to rituximab or severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibodies
  • Prior allogeneic hematopoietic stem cell transplant (HSCT)
  • Known Central Nervous System (CNS) lymphoma; subjects with symptoms of CNS disease must have a negative CT scan and negative diagnostic lumbar puncture
  • Prior treatment with a PI3K inhibitor or BTK inhibitor
  • History of tuberculosis within the preceding two years
  • Ongoing systemic bacterial, fungal, or viral infections at randomization (defined as requiring IV antimicrobial, antifungal or antiviral agents)
  • Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other I/E criteria are met
  • Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis C virus antibodies (HCV Ab)
  • History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   France,   Italy,   Poland
Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Germany,   Hungary,   Israel,   New Zealand,   Spain,   United Kingdom,   United States
 
NCT02204982
IPI-145-08
2013-002406-31 ( EudraCT Number )
Yes
Not Provided
Not Provided
Verastem, Inc.
Verastem, Inc.
Not Provided
Study Chair: Hagop Youssoufian, MD Verastem, Inc.
Verastem, Inc.
May 2018

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