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

NCT02204982 | Terminated Phase 3 Results DMC

• 2 other identifiers: IPI-145-082013-002406-31
• Study Type: interventional
• Target: 13
• Locations: 4 countries
• Sites: 5

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.

Conditions

Follicular Lymphoma

Keywords

Phase 3, Follicular Lymphoma, FL, PI3K

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Due to the small number of enrolled subjects and study being terminated, PFS endpoint analysis was not performed.

  Until disease progression, for up to 5 years from randomization

Secondary Outcomes (1)

• Overall Response Rate (ORR)

  Until disease progression, for up to 5 years from randomization

Study Arms (2)

Duvelisib + Rituximab

EXPERIMENTAL

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.

Drug: Duvelisib; Drug: Rituximab

Placebo + Rituximab

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Rituximab

Interventions

Duvelisib DRUG

PI3K Inhibitor

Also known as: Copiktra, IPI-145

Duvelisib + Rituximab

Placebo DRUG

Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.

Placebo + Rituximab

Rituximab DRUG

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.

Also known as: Rituxan, MabThera

Duvelisib + Rituximab; Placebo + Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SecuraBio: lead

Study Sites (5)

Unknown Facility

Frankston, Victoria, 3199, Australia

Location

Unknown Facility

Bordeaux, 33076, France

Location

Unknown Facility

Bologna, 40138, Italy

Location

Unknown Facility

Terni, 05100, Italy

Location

Unknown Facility

Gdynia, 81-519, Poland

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Hereditary Sensory and Autonomic Neuropathies

Interventions

duvelisib; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Beth Gregory, PharmD, MBA
• Organization: Secura Bio, Inc.

bgregory@securabio.com

1-702-254-0011

Study Officials

• Hagop Youssoufian, MD

  Verastem, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 31, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: September 28, 2023
• Results First Posted: January 3, 2019

Record last verified: 2023-09

Locations

PL (1); FR (1); IT (2); AU (1)