A clinical trial which compares the safety and efficacy of chemotherapy (Rituximab and Bendamustine ) combined with Duvelisib, the study treatment, or a placebo in patients who have previously treated Indolent Non-Hodgkin Lymphoma.
- Conditions
- Indolent Non-Hodgkin LymphomaMedDRA version: 18.1Level: HLTClassification code 10029621Term: Non-Hodgkin's lymphomas unspecified histology indolentSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004033-28-HU
- Lead Sponsor
- Infinity Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
• = 18 years of age
• Diagnosis of iNHL with one of the following histologic sub-types and grade:
- Follicular lymphoma (FL)Grade 1, 2, or 3a
- Small lymphocytic lymphoma (SLL)
- Marginal zone lymphoma (MZL)( splenic, nodal, or extranodal)
• Have received the following systemic treatments for iNHL:
- an anti-CD20 antibody; and
- chemotherapy
• At least 1 measurable disease lesion > 1.5 cm in at least one dimension by computed tomography (CT)/CT-PET or magnetic resonance imaging (MRI)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (corresponds to Karnofsky Performance Status [(KPS) =60%])
For full inclusion criteria list, refer to protocol.
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 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180
• Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B FL
• Refractory to BR, defined as:
- Progression of disease while receiving or within 6 months of completing bendamustine + rituximab therapy
• Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
• Received prior allogeneic transplant
• Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
• Infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
• History of tuberculosis treatment within the two years prior to randomization
• History of chronic liver disease, veno-occlusive disease, or alcohol abuse
• Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) daily (QD)
• Ongoing treatment for systemic bacterial, fungal, or viral infection at screening
• Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
• Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia
• History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening
For full exclusion criteria list, refer to protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method