Status:
TERMINATED
Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
Lead Sponsor:
SecuraBio
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 follicula...
Detailed Description
Study IPI-145-08 is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of duvelisib in combination ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02204982
Start Date
September 1 2014
End Date
March 1 2017
Last Update
September 28 2023
Active Locations (5)
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1
Frankston, Victoria, Australia, 3199
2
Bordeaux, France, 33076
3
Bologna, Italy, 40138
4
Terni, Italy, 05100