Follicular Lymphoma MedDRA version: 18.1 Level: LLT Classification code 10025311 Term: Lymphoma (non-Hodgkin's) System Organ Class: 100000004864
Conditions
Interventions
Product Name: IPI-145
Product Code: IPI-145
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Duvelisib
CAS Number: 1386861-48-9
Current Sponsor code: IPI-145
Other descriptive name: IPI-145
Con
Sponsors
Infinity Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Diagnosis of CD20+ FL that has not been treated ·CD20-immunophenotyping of tumor to document B-cell follicular lymphoma ·Stage II with bulky disease (=7 cm lesion), or Stage III or IV disease ·At least 1 measurable disease lesion >1.5 cm in at least one dimension ·Disease that requires treatment based on the investigator’s opinion (based on clinical status of the subject or established criteria such as Groupe d'Etude des Lymphomes Folliculaires [GELF]) ·Eastern Cooperative Oncology Group (ECOG) performance status =2 (corresponds to Karnofsky Performance Status [KPS] >60%)Performance Status [KPS] =60%) 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy. • Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B follicular lymphoma • Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs • Prior allogeneic hematopoietic stem cell transplant • Prior, current or chronic hepatitis B or hepatitis C infection • Human immunodeficiency virus (HIV) infection or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the safety and assess the clinical activityof IPI-145 in combination with rituximab or obinutuzumab in subjects with previously untreated CD20+ follicular lymphoma (FL);Secondary Objective: ·Evaluate the safety of duvelisib in combination with rituximab ·Evaluate the safety of duvelisib in combination with obinutuzumab ·Evaluate the pharmacokinetics (PK) of duvelisib in combination with rituximab or obinutuzumab;Primary end point(s): Primary Endpoint (Part 1): • Dose limiting toxicities Primary Endpoint (Part 2): • Complete Response Rate (CRR), with CR defined according to the revised International Working Group (IWG) Criteria;Timepoint(s) of evaluation of this end point: Primary Endpoint (Part 1): After approximately 6-30 subjects are enrolled and treated for 1 cycle in each treatment arm Primary Endpoint (Part 2): Approximately 6 months after last subject is enrolled. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values • Overall Response Rate (ORR) • Duration of response (DOR) • Overall survival (OS) • Pharmacokinetic (PK) parameters of IPI-145 and its major metabolite;Timepoint(s) of evaluation of this end point: Secondary Endpoints (Part 1 and Part 2): Approximately 6 months after last subject is enrolled. | — |
Countries
Belgium, France, Italy, Spain, United Kingdom, United States
Contacts
Public ContactIPI-145-19 Trial Information
Infinity Pharmaceuticals, Inc.
Outcome results
None listed