Study to evaluate the efficacy of IPI-145 administered in combination with rituximab vs placebo in combination with rituximab in subjects with previously treated CD20-positive FL

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of IPI-145 in Combination with Rituximab vs Rituximab in Subjects with Previously-Treated Follicular Lymphoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002406-31-GB

Enrollment

400

Registered

2014-07-08

Start date

2015-01-07

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Lymphoma MedDRA version: 17.0 Level: LLT Classification code 10025311 Term: Lymphoma (non-Hodgkin's) System Organ Class: 100000004864

Interventions

Product Name: IPI-145 Product Code: IPI-145 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Not yet available CAS Number: 1386861-48-9 Other descriptive name: IPI-145 Concentration unit: mg mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Diagnosis of CD20-positive FL: oHistology grades 1, 2 or 3a o Biopsy confirmed histopathological diagnosis of FL. Biopsy specimen should be obtained =2 years prior to randomization, unless medically contraindicated o CD20 immunophenotyping performed =65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

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 treatment with a PI3K inhibitor or BTK inhibitor

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of IPI-145 administered in combination with rituximab vs placebo in combination with rituximab in subjects with previously-treated CD20-positive follicular lymphoma (FL);Secondary Objective: •To evaluate the safety of IPI-145 in combination with rituximab in subjects with previously-treated CD20-positive FL •To characterize the pharmacokinetics (PK) of IPI-145 when administered in combination with rituximab ;Primary end point(s): Progression-free survival (PFS). Progression will be based on blinded independent central review.;Timepoint(s) of evaluation of this end point: •Every 4 cycles for 27 cycles. •Day 1, Cycle 28, subjects who receive IPI-145/placebo beyond 27 cycles will return to the clinic every even cycle through the end of their treatment or until disease progression. Disease response assessments will continue every 6 cycles for those subjects who continue treatment	—

Measure

Time frame

Main Objective: To evaluate the efficacy of IPI-145 administered in combination with rituximab vs placebo in combination with rituximab in subjects with previously-treated CD20-positive follicular lymphoma (FL);Secondary Objective: •To evaluate the safety of IPI-145 in combination with rituximab in subjects with previously-treated CD20-positive FL •To characterize the pharmacokinetics (PK) of IPI-145 when administered in combination with rituximab ;Primary end point(s): Progression-free survival (PFS). Progression will be based on blinded independent central review.;Timepoint(s) of evaluation of this end point: •Every 4 cycles for 27 cycles. •Day 1, Cycle 28, subjects who receive IPI-145/placebo beyond 27 cycles will return to the clinic every even cycle through the end of their treatment or until disease progression. Disease response assessments will continue every 6 cycles for those subjects who continue treatment

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: •Every 4 cycles for 27 cycles. •Day 1, Cycle 28, subjects who receive IPI-145/placebo beyond 27 cycles will return to the clinic every even cycle through the end of their treatment or until disease progression. Disease response assessments will continue every 6 cycles for those subjects who continue treatment •OS follow up and relevant PK and safety visits;Secondary end point(s): •ORR , CR, OS, DOR , TTR , EFS, PK and Safety	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: •Every 4 cycles for 27 cycles. •Day 1, Cycle 28, subjects who receive IPI-145/placebo beyond 27 cycles will return to the clinic every even cycle through the end of their treatment or until disease progression. Disease response assessments will continue every 6 cycles for those subjects who continue treatment •OS follow up and relevant PK and safety visits;Secondary end point(s): •ORR , CR, OS, DOR , TTR , EFS, PK and Safety

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Countries

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

Contacts

Public ContactJill Rodstrom

Infinity Pharmaceuticals, Inc

Jill.Rodstrom@Infi.com0016174531288

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026