CLINICAL DEVELOPMENT

ongoing clinical trials

The information presented below does not make any claims with regard to safety or efficacy. There are no guarantees that the outcomes of these studies will result in regulatory approval(s).

DUVELISIB

StudyTherapeutic AreaEnrollment StatusPhase 1 2 3 4
StudyTERZO
NCT06522737		Therapeutic AreaRelapsed or Refractory Nodal T Cell Lymphoma with T Follicular Helper PhenotypeEnrollment StatusNot Yet Recruiting to Phase 3Phase 1 2 3 4

Title

TERZO: A Phase 3, Randomized Trial of Duvelisib in Patients with TFH Phenotype T-Cell Lymphoma

Study Description

A multicenter, open-label, phase 3, randomized controlled trial of duvelisib versus investigator’s choice of gemcitabine or bendamustine in patients with relapsed/refractory nodal T cell lymphoma with T follicular helper phenotype:

TEMPO Intermittent dosing chart TEMPO Intermittent dosing chart
  • Patients will receive treatment until PD or unacceptable toxicity
  • All patients will be followed for survival for a maximum of 3 years from randomization
Outcome Measures
Primary

Progression-free survival

Key Secondary
  • Overall survival (OS)
Select Secondary#
  • Objective response rate**
  • CR rate**
  • Duration of response**
  • Number of participants with adverse events
  • Quality of life
Eligibility Criteria
Inclusion Criteria
  • Pathologically confirmed nodal T-cell lymphoma with TFH phenotype according to the criteria of the World Health Organization classification, including any one of angioimmunoblastic T-cell lymphoma (AITL), follicular T-cell lymphoma, and other nodal peripheral T-cell lymphoma (PTCL) with a TFH phenotype
  • Relapsed or refractory to at least 1 prior systemic, cytotoxic therapy for T-cell lymphoma
  • Measurable disease as defined by Lugano 2014 criteria for T-cell lymphoma
Exclusion Criteria
  • Cutaneous-only disease
  • Received prior allogeneic transplant any time in the past or autologous transplant within 60 days prior to the first dose of study drug
  • Received prior treatment with a PI3K inhibitor
  • Prior exposure to planned study treatment investigator's choice therapy (gemcitabine or bendamustine) within 60 days prior to the first dose of study drug

*Includes AITL, follicular T-cell lymphoma, and other nodal PTCL with a TFH phenotype (see Swerdlow SH, et al. WHO Classification of Tumours of Haematopoietic and Lymphoid TIssues, 4th ed, 2017; Alaggio R, et al. Leukemia. 2022;36[7]:1720-1748).

†Randomization stratified by AITL score (0-2 vs 3-4), number of prior lines of therapy for T-cell lymphoma (1 vs >1), and country.

‡Investigator choice of comparator (gemcitabine or bendamustine) must be declared prior to randomization.

§Response assessment per 2014 Lugano criteria (Cheson BD, et al. J Clin Oncol. 2014;32[27]:3059-3068).

||In the bendamustine arm, response assessment occurs every 6 weeks until end of treatment.

Defined as time from randomization to documented PD, according to 2014 Lugano criteria as assessed by IRC, or death due to any cause.

#Additional measures apply.

**As assessed by IRC.

CR, complete response; ECOG, Eastern Cooperative Oncology Group; IRC, independent review committee; PD, progressive disease; PI3K, phosphatidylinositol 3-kinase; PR, partial response; R/R, relapsed or refractory; SCT, stem cell transplant; SD, stable disease; TFH, T follicular helper; WHO, World Health Organization.

For complete trial information, visit https://ClinicalTrials.gov/ct2/show/NCT06522737.
StudyTherapeutic AreaEnrollment StatusPhase 1 2 3 4
StudyPRIMO Single-agent
NCT03372057		Therapeutic AreaRelapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)StatusCompletePhase 1 2 3 4

Title

A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)

Study Description

This multicenter, phase 2, open-label, parallel-cohort efficacy and safety study contains 2 phases: a dose optimization phase and an expansion phase:

PRIMO Single-agent chart PRIMO Single-agent chart
Outcome Measures
Primary

Objective response rate (ORR [CR + PR])

Select Secondary†
  • Duration of response
  • Disease control rate
  • Progression-free survival
  • Overall survival
  • Safety
Eligibility Criteria
Inclusion Criteria
  • Age ≥18 years of age
  • Diagnosis of one of the following histologic subtypes of PTCL, pathologically confirmed, as defined by the World Health Organization:
    • Peripheral T-cell lymphoma–not otherwise specified (PTCL-NOS);
    • Angioimmunoblastic T-cell lymphoma (AITL);
    • Anaplastic large cell lymphoma (ALCL); or
    • Natural-killer/T-cell lymphoma (NKTL)
  • Received at least 2 cycles of one standard regimen for newly diagnosed advanced PTCL, and one of the following:
    • Failed to achieve at least a PR after 2 or more cycles of standard therapy;
    • Failed to achieve a CR after completion of standard therapy; and/or
    • Persistent or progressive disease after an initial response
  • For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
  • Measurable disease as defined by Lugano for PTCL, that is, at least 1 measurable disease lesion >1.5 cm in at least one dimension by conventional techniques (18FDG-PET-CT, CT with contrast, MRI)
Exclusion Criteria
  • Primary leukemic PTCL subtypes (that is, T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia, adult T-cell leukemia/lymphoma, and aggressive NK-cell leukemia) or transformed mycosis fungoides
  • Received prior allogeneic transplant
  • Received prior treatment with a PI3K inhibitor
  • Known central nervous system involvement by PTCL
  • Ongoing treatment with chronic immunosuppressants (eg, cyclosporine) or systemic steroids >20 mg of prednisone (or equivalent) once daily (QD)
  • Ongoing treatment for systemic bacterial, fungal, or viral infection at screening
  • Known hypersensitivity to duvelisib and/or its excipients

*Estimated enrollment.

†Additional measures apply.

18F-FDG PET/CT, 18-fluorine fluorodeoxyglucose positron emission tomography/computed tomography; BID, twice daily; CD30+, cluster of differentiation 30 positive; CR, complete response; CT, computed tomography; MRI, magnetic resonance imaging; PI3K, phosphoinositide 3-kinase; PO, orally; PR, partial response; PTCL, peripheral T-cell lymphoma.

For complete trial information, visit https://ClinicalTrials.gov/ct2/show/NCT03372057.
StudyTherapeutic AreaEnrollment StatusPhase 1 2 3 4
StudyTEMPO Intermittent dosing
NCT04038359		Therapeutic AreaIndolent Non-Hodgkin Lymphoma (iNHL)StatusCompletePhase 1 2 3 4

Title

A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma (iNHL) (TEMPO)

Study Description

This phase 2, randomized, open-label, 2-arm study is designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in subjects with relapsed or refractory (R/R) iNHL who have received at least 1 prior systemic therapy. Patient arms are based on 2 different dosing schedules:

TEMPO Intermittent dosing chart TEMPO Intermittent dosing chart
Outcome Measures
Primary

Overall response rate

Select Secondary*
  • Overall response rate at 6, 12, 18, and 24 months
  • Progression-free survival
  • Time to treatment failure
  • Duration of response
  • Overall survival
  • Lymph node response rate
  • Time to first response
  • Safety
Eligibility Criteria
Inclusion Criteria
  • ECOG performance status ≤2
  • Histologically confirmed diagnosis of iNHL (subtypes include follicular lymphoma 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 bidimensionally 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 × 109/liter (L)
    • Platelet count ≥75 × 109/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, Grade 3b follicular lymphoma, Richters' transformation, or chronic lymphocytic leukemia
  • Prior allogeneic hematopoietic stem cell transplant or prior treatment with a PI3K inhibitor
  • History of drug-induced colitis or pneumonitis, tuberculosis treatment ≤2 years prior to randomization, or 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

*Additional measures apply.

BID, twice daily; ECOG, Eastern Cooperative Oncology Group; PI3K, phosphoinositide 3-kinase.

For complete trial information, visit https://Clinica1Trials.qov/ct2/show/NCT04038359.

INVESTIGATOR SPONSORED STUDIES

If you're interested in submitting a proposal for an investigator sponsored study, you can contact us at iss@securabio.com.

AREAS OF RESEARCH INTEREST WITH DUVELISIB

Areas of interest to the clinical development program include:

  • CLL/SLL
  • iNHL
  • T-cell lymphoma
  • Select solid tumors
  • Real-world data
  • Health economics and outcomes research
  • Novel dosing and dosing schedules

Also being considered for hematologic malignancies and solid tumors are combination regimens with:

  • CAR T-cell therapies
  • Bispecific antibodies
  • Immunotherapies
  • BTK and BCL2 inhibitors
  • Other therapies with novel mechanisms of action
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CONTINUING MEDICAL EDUCATION (CME) GRANTS

If you're interested in submitting a request for a CME grant, you can contact us at grants@securabio.com.

BCL2, B-cell lymphoma 2; BTK, Bruton tyrosine kinase; CAR T, chimeric antigen receptor T cell; CLL/SLL, chronic lymphocytic leukemia/small lymphocytic lymphoma; iNHL, indolent non-Hodgkin lymphoma.