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 F

Phase 1

Conditions: Follicular Lymphoma
MedDRA version: 18.1Level: LLTClassification code 10025311Term: Lymphoma (non-Hodgkin's)System Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-002406-31-PL

Lead Sponsor: Infinity Pharmaceuticals, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

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 =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
oPatients 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>•To characterize the pharmacokinetics (PK) of IPI-145 when administered in combination with rituximab<br>;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. <br>•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<br><br>

Secondary Outcome Measures

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