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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 March 2021
• Main ID: NCT02204982
• Date of registration: 25/07/2014
• Prospective Registration: Yes
• Primary sponsor: SecuraBio
• Public title: Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma DYNAMO + R
• Scientific 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
• Date of first enrolment: September 2014
• Target sample size: 13
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02204982
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Spain, United Kingdom, United States

Contacts

• Name: Hagop Youssoufian, MD
• Affiliation: Verastem, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Follicular Lymphoma

Intervention(s)

Drug: Duvelisib

Drug: Rituximab

Drug: Placebo

Primary Outcome(s)

Progression-Free Survival (PFS) [Time Frame: Until disease progression, for up to 5 years from randomization]

Secondary Outcome(s)

Overall Response Rate (ORR) [Time Frame: Until disease progression, for up to 5 years from randomization]

Secondary ID(s)

2013-002406-31

IPI-145-08

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02204982