A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma (TEMPO)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.
Full 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) indolent non-Hodgkin lymphoma (iNHL) who have received at least 1 prior systemic therapy.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
-
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 criteria
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
103 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal