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Phase 2 Completed N=103 Randomized Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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