Phase 2
Completed N=103
A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma
Source: ClinicalTrials.gov NCT04038359 ↗Enrolled (actual)
103
Serious AEs
28.4%
Results posted
Sep 2024
Primary outcomePrimary: Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria — 65.3; 52.9; 62.2; 54.3 percentage of participants
Summary
This study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria |
65.3; 52.9; 62.2; 54.3 | — |
| SECONDARY Progression-free Survival (PFS) |
16.0; 23.0; 16.0; 23.0 | — |
| SECONDARY ORR At Specific Timepoints |
63.3; 49.0; 65.3; 52.9; 65.3; 52.9 | — |
| SECONDARY Duration of Response (DOR) |
21.4; 32.2; 21.4; 32.2 | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Lymph Node Response Rate (LNRR) |
64.3; 60.9 | — |
| SECONDARY Time To First Response (TTFR) |
2.30; 2.30; 2.30; 2.30 | — |
| SECONDARY Time To Treatment Failure (TTF) |
12.6; 14.3 | — |
| SECONDARY ORR According to 2014 Lugano Criteria |
65.3; 51.0; 62.2; 52.2 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04038359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.