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

Primary Purpose

Follicular Lymphoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Duvelisib
Placebo
Rituximab
Sponsored by
SecuraBio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring Phase 3, Follicular Lymphoma, FL, PI3K

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Duvelisib + Rituximab

Placebo + Rituximab

Arm Description

Duvelisib 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.

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.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
Due to the small number of enrolled subjects and study being terminated, PFS endpoint analysis was not performed.

Secondary Outcome Measures

Overall Response Rate (ORR)

Full Information

First Posted
July 25, 2014
Last Updated
September 7, 2023
Sponsor
SecuraBio
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1. Study Identification

Unique Protocol Identification Number
NCT02204982
Brief Title
Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
Acronym
DYNAMO + R
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor is focusing on studies which can enable registration of duvelisib
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SecuraBio

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study to evaluate the safety and efficacy of duvelisib 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.
Detailed Description
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 duvelisib 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 duvelisib 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
Keywords
Phase 3, Follicular Lymphoma, FL, PI3K

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duvelisib + Rituximab
Arm Type
Experimental
Arm Description
Duvelisib 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.
Arm Title
Placebo + Rituximab
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Duvelisib
Other Intervention Name(s)
Copiktra, IPI-145
Intervention Description
PI3K Inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Due to the small number of enrolled subjects and study being terminated, PFS endpoint analysis was not performed.
Time Frame
Until disease progression, for up to 5 years from randomization
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Time Frame
Until disease progression, for up to 5 years from randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagop Youssoufian, MD
Organizational Affiliation
Verastem, Inc.
Official's Role
Study Chair
Facility Information:
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Terni
ZIP/Postal Code
05100
Country
Italy
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma

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