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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Indolent Non-Hodgkin Lymphoma

Clinical Trials on Duvelisib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings