EUCTR2019-001381-14-ITActive, not recruitingPhase 1
A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 IntermittentDosing Schedules of Duvelisib in Subjects with Indolent Non-Hodgkin Lymphoma (iNHL) -
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Verastem, INC
- Enrollment
- 102
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male or female subjects >= 18 years of age
- •2. Histologically confirmed diagnosis of iNHL. Histologic subtypes includeFL Grades 1 to 3a, marginal zone lymphoma (splenic, nodal, or extranodal), or SLL.
- •3. Must have received at least 1 prior systemic regimen for iNHL
- •4. Must have documented radiologic evidence of disease progression, at least 1 Bidimensionally measurable lesion >= 1.5 cm (which has not been previously irradiated),according to 2007 revised IWG criteria (Cheson 2007) and be a candidate for a subsequent line of therapy
- •5. Must have adequate organ function defined by the following laboratory parameters:
- •a. Absolute neutrophil count (ANC) >= 1.0 × 109/L
- •b. Platelet count >= 75 × 109/L
- •c.Hemoglobin = 8 g/dL
- •d.Estimated creatinine clearance (eCCr) = 60 mL/min, as determined by the Cockcroft-Gault method (Cockcroft 1976)
- •e. Total bilirubin <= 1.5 × upper limit of normal (ULN) (exception: subjects with Gilbert's Syndrome may have a bilirubin > 1.5 × ULN)
- •f. Aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum pyruvic transaminase (SGPT) <= 3.0 × ULN
- •6. Eastern Cooperative Oncology Group (ECOG) performance status <= 2
- •7. Male and female subjects of reproductive potential (i.e., not surgically sterile or female subjects who are not postmenopausal) must be willing to use highly effective methods of contraception (see Section 10.4) for the duration of the study intervention and for 3 months after the last dose of duvelisib
- •8. Negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days before first dose of study intervention if the subject is a woman of childbearing potential(WCBP) (defined in Section 10.4)
- •9. Signed and dated institutional review board (IRB)/independent ethics committee (IEC)-approved informed consent form before any study specific-screening procedures are performed
- •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 51
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 51
Exclusion Criteria
- •1. Anticancer treatment, major surgery, or use of any investigational drug within 28 days before the start of study intervention; palliative radiation therapy is allowed if > 7 days before planned first dose of study interventions and any toxicity is Grade <= 1.
- •2. Clinical or histological evidence of transformation to a more aggressive subtype of Lymphoma or grade 3b FL or Richter's transformation or CLL
- •3. Received prior allogeneic hematopoietic stem cell transplant (HSCT)
- •4. Previous treatment with a PI3K inhibitor
- •5. Known hypersensitivity to duvelisib and/or its excipients
- •6. History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function
- •7. Prior history of drug-induced colitis or drug-induced pneumonitis
- •8. History of tuberculosis treatment within the 2 years prior to randomization
- •9. Administration of a live or live attenuated vaccine within 6 weeks of randomization
- •10. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) per day
- •11. Ongoing treatment for systemic bacterial, fungal, or viral infection at screening
- •Note: Subjects on antimicrobial, antifungal, or antiviral prophylaxis arenot specifically excluded if all other inclusion/exclusion criteria are met
- •12. Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection (i.e., subjects with detectable viral load)
- •13. Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
- •14. Infection with hepatitis B, hepatitis C,or human immunodeficiency virus (HIV)
- •Subjects with a positive hepatitis B surface antigen [HBsAg] or hepatitis C antibody[HCV Ab] will be excluded
- •Subjects with a positive hepatitis B core antibody (HBcAb) must have negative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) to be eligible and must be periodically monitored for HBV reactivation by institutional guidelines
- •Investigators who strongly believe that a positive HBcAb is false due to passive immunization from previous immunoglobulin infusion therapy should discuss the potential to defer HBV prophylaxis with the Medical Monitor
- •15. Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start of study intervention.
- •16. Subjects with clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea,vomiting, or any other condition that will interfere significantly with drug absorption
- •For other Exclusion Criteria, please, see the protocol.
Investigators
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