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

February 5, 2024 updated by: SecuraBio

A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma (iNHL)

This study will examine the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in subjects with R/R iNHL who have received at least 1 prior systemic therapy.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Hradec Králové, Czechia, 500 05
        • FN Hradec Králové
      • Praha 2, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
  • Germany
      • Bonn, Germany, 53127
        • Universitaetsklinikum Bonn AöR
  • Italy
      • Milano, Italy, 20141
        • IEO - Istituto Europeo di Oncologia, IRCCS
      • Reggio Emilia, Italy, 42123
        • AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio Emilia
      • Terni, Italy, 05100
        • Azienda Ospedaliera Santa Maria di Terni
      • Varese, Italy, 21100
        • Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fondazione Macchi
    • Forli
      • Meldola, Forli, Italy, 47014
        • Oncology Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
  • Korea, Republic of
      • Seongnam-si, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center - Oncology
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center - Hematology-Oncology
  • Poland
      • Katowice, Poland, 40-519
        • Pratia Onkologia Katowice
      • Skórzewo, Poland, 60-185
        • Centrum Medyczne Pratia Poznan
    • Pomorskie
      • Slupsk, Pomorskie, Poland, 76-200
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
  • Russian Federation
      • Moscow, Russian Federation, 125284
        • City Clinical Hospital n.a. Botkin
      • Moscow, Russian Federation, 108814
        • State Budgetary Healthcare Institution of Moscow City Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Healthcare of Moscow City
      • Sankt-Peterburg, Russian Federation, 197022
        • First Saint-Petersburg State Medical University n.a. I.P. Pavlov
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • NHS Greater Glasgow & Clyde - CRUK Clinical Trials Unit
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool Hospital [Hematology/Transfusion Medicine]
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust
  • United States
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists - Fort Myers
      • Lecanto, Florida, United States, 34461
        • Florida Cancer Specialists & Research Institute - Lecanto
      • Orange City, Florida, United States, 32763
        • Mid-Florida Cancer Centers
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Robert H. Lurie Comprehensive Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years, ECOG performance status ≤ 2
  • Histologically confirmed diagnosis of iNHL (Subtypes include FL Grades 1 to 3a, marginal zone lymphoma (splenic, nodal, or extranodal), or SLL
  • 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 cm (which has not been previously irradiated), according to 2007 revised IWG 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 (ANC) ≥ 1.0 × 10^9/L
    • Platelet count ≥ 75 × 10^9/L
    • Hemoglobin ≥ 8 g/dL
    • Estimated creatinine clearance ≥ 60 mL/min, as determined by the Cockcroft-Gault method
    • Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (exception: subjects with Gilbert's Syndrome may have a bilirubin > 1.5 × ULN)
    • Aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum pyruvic transaminase (SGPT) ≤ 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 CLL
  • Prior allogeneic hematopoietic stem cell transplant (HSCT); prior treatment with a PI3K inhibitor
  • History of drug-induced colitis or pneumonitis; TB 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 (CMV) or Epstein-Barr virus (EBV) infection
  • Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
  • Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start of study intervention.
  • Baseline QTcF > 500 ms
  • Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix, bladder cancer, or prostate cancer not requiring treatment. Subjects 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 subject's risk to participating in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duvelisib, Intermittent Dosing
Duvelisib 25 mg BID dosed two weeks on and two weeks off.
Drug: Duvelisib
PI3K Inhibitor
Other Names:
  • Copiktra, VS-0145
Experimental: Duvelisib, Continuous and Intermittent Dosing
Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed two weeks on and two weeks off of each subsequent 4-week cycle.
Drug: Duvelisib
PI3K Inhibitor
Other Names:
  • Copiktra, VS-0145

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR (Overall Response Rate)
Time Frame: 14 months
Proportion of subjects achieving a CR or PR will be estimated as per IWG Criteria.
14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS (Progression-free Survival)
Time Frame: 2 years
From time of first dose of study intervention to PD or death.
2 years
ORR (Overall Response Rate)
Time Frame: ORR estimated at 6, 12, 18, and 24 months after first dose of study intervention.
Proportion of subjects achieving a CR or PR will be estimated as per IWG Criteria and Lugano Criteria
ORR estimated at 6, 12, 18, and 24 months after first dose of study intervention.
DOR (Duration of Response)
Time Frame: 2 years
From the time of first response to PD using KM methods.
2 years
OS (Overall Survival)
Time Frame: 2 years
From time of first dose of study intervention to death.
2 years
LNRR (Lymph Node Response Rate)
Time Frame: 14 months
LNRR will be calculated as the proportion of subjects achieving ≥ 50% decrease in the SPD of target lymph nodes.
14 months
TTFR (Time To First Relapse)
Time Frame: 14 months
From the time of first dose of study intervention to time of first CR or PR.
14 months
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Time Frame: 14 months
From the time of screening to the end of Safety Follow-Up period of the study.
14 months
Peak Plasma Concentration (Cmax)
Time Frame: 14 months
14 months
TTF (Time To Treatment Failure)
Time Frame: 2 years
From first dose of study intervention until discontinuation for any reason and will be summarized using KM methods.
2 years
Area under the plasma concentration versus time curve (AUC)
Time Frame: 14 months
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SecuraBio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2019

Primary Completion (Actual)

July 24, 2023

Study Completion (Actual)

July 24, 2023

Study Registration Dates

First Submitted

July 10, 2019

First Submitted That Met QC Criteria

July 26, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VS-0145-229
  • 2019-001381-14 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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