Status:
COMPLETED
A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma
Lead Sponsor:
SecuraBio
Conditions:
Indolent Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.
Detailed Description
This was a Phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in participants with relapsed or refractory (R/R...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group performance status ≤ 2
- Histologically confirmed diagnosis of iNHL (subtypes include follicular lymphoma \[FL\] Grades 1 to 3a), marginal zone lymphoma (splenic, nodal, or extranodal), or small lymphocytic lymphoma
- Must have received 1 prior systemic regimen for iNHL
- Must have documented radiologic evidence of disease progression, at least 1 bi-dimensionally measurable lesion ≥ 1.5 centimeters (which has not been previously irradiated), according to 2007 revised International Working Group criteria, and be a candidate for a subsequent line of therapy.
- Must have adequate organ function defined by the following laboratory parameters:
- Absolute neutrophil count ≥ 1.0 × 10\^9/liter (L)
- Platelet count ≥ 75 × 10\^9/L
- Hemoglobin ≥ 8 grams/deciliter
- Estimated creatinine clearance ≥ 60 milliliters/minute, as determined by the Cockcroft-Gault method
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (exception: participants with Gilbert's Syndrome may have a bilirubin \> 1.5 × ULN)
- Aspartate transaminase/serum glutamic-oxaloacetic transaminase and alanine aminotransferase/serum pyruvic transaminase ≤ 3.0 × ULN
Exclusion
- 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
- Clinical or histological evidence of transformation to a more aggressive subtype of lymphoma or grade 3b FL or Richters' transformation or chronic lymphocytic leukemia
- Prior allogeneic hematopoietic stem cell transplant; prior treatment with a PI3K inhibitor
- History of drug-induced colitis or pneumonitis; tuberculosis treatment ≤ 2 years prior to randomization; administration of a live or live attenuated vaccine within 6 weeks of randomization
- Ongoing treatment with chronic immunosuppressants or systemic steroids or treatment for systemic bacterial, fungal, or viral infection
- Active cytomegalovirus or Epstein-Barr virus infection
- Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus, or herpes zoster at screening
- Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A. No prior use within 2 weeks before the start of study intervention.
- Baseline QT interval corrected with Fridericia's method \> 500 milliseconds
- Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix, bladder cancer, or prostate cancer not requiring treatment. Participants with previous malignancies are eligible if they have been disease-free for 2 years or more.
- Unstable or severe uncontrolled medical condition that would, in the Investigator's judgment, increase the participant's risk to participating in this study.
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2023
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04038359
Start Date
September 24 2019
End Date
July 24 2023
Last Update
September 19 2024
Active Locations (28)
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1
Florida Cancer Specialists - Fort Myers
Fort Myers, Florida, United States, 33901
2
Florida Cancer Specialists & Research Institute - Lecanto
Lecanto, Florida, United States, 34461
3
Mid-Florida Cancer Centers
Orange City, Florida, United States, 32763
4
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611