Indolent Non-Hodgkin LymphomaPhase 2TEMPONCT04038359
A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma
A Phase 2 study testing Duvelisib in people with Indolent Non-Hodgkin Lymphoma, run by SecuraBio at 28 sites in 8 countries.
Trial summary
This study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indolent Non-Hodgkin Lymphoma
- What is being tested?
- Duvelisib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 28 sitesin 8 countries
- Study dates
- 24 Sep 2019to 24 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
28 sites in 8 countries.
28 sites in 8 countries
United States6 sites
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
Florida Cancer Specialists - Fort Myers
Fort Myers, Florida, 33901
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Florida Cancer Specialists & Research Institute - Lecanto
Lecanto, Florida, 34461
Tennessee Oncology
Nashville, Tennessee, 37203
Mid-Florida Cancer Centers
Orange City, Florida, 32763
Italy5 sites
Oncology Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
Meldola, Forli, 47014
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, 20141
AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio Emilia
Reggio Emilia, 42123
Azienda Ospedaliera Santa Maria di Terni
Terni, 05100
Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fondazione Macchi
Varese, 21100
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam-si, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center - Oncology
Seoul, 05505
Samsung Medical Center - Hematology-Oncology
Seoul, 06351
Poland3 sites
Pratia Onkologia Katowice
Katowice, 40-519
Centrum Medyczne Pratia Poznan
Skórzewo, 60-185
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
Słupsk, Pomeranian Voivodeship, 76-200
Russia3 sites
State Budgetary Healthcare Institution of Moscow City Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Healthcare of Moscow City
Moscow, 108814
City Clinical Hospital n.a. Botkin
Moscow, 125284
First Saint-Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg, 197022
United Kingdom3 sites
NHS Greater Glasgow & Clyde - CRUK Clinical Trials Unit
Glasgow, G12 0YN
Royal Liverpool Hospital [Hematology/Transfusion Medicine]
Liverpool, L7 8XP
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX
Czechia2 sites
FN Hradec Kralove
Hradec Králové, 500 05
Vseobecna fakultni nemocnice v Praze
Prague, 128 08
About this study
Official title: 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 examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.
Read the detailed description
This was a Phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in participants with relapsed or refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who have received at least 1 prior systemic therapy.
- Conditions
- Indolent Non-Hodgkin Lymphoma
- Being tested
- Duvelisib
- Keywords
- PI3K Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvelisibDrug
Also called Copiktra, VS-0145, IPI-145
Phosphoinositide 3-kinase (PI3K) inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Duvelisib, Continuous and Intermittent Dosing | Experimental | Duvelisib 25 milligrams (mg) twice daily (BID) continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on for each subsequent 4-week cycle. Receives: Drug: Duvelisib |
| Duvelisib, Intermittent Dosing | Experimental | Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off. Receives: Drug: Duvelisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria
ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites.
Measured: Up to 14 months
Secondary outcomes (8)
Progression-free Survival (PFS)
PFS was defined as the time from first dose to first progressive disease (PD) or death (progression date/death date - treatment start date + 1) or, for participants without PD or documented death, as the time from first dose to censoring date (censoring date - treatment start date + 1). The 2007 revised IWG criteria defined PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined PD as a progressive metabolic response (according to positron emission tomography-computed tomography [PET-CT]) and progressive disease (according to computed tomography [CT]). Results reported as months.
Measured: Up to 2 years
ORR At Specific Timepoints
ORR at 6, 12, 18, and 24 months after first dose of study intervention was defined as the percentage of participants achieving CR or PR at each timepoint and was assessed using both the 2007 revised IWG criteria and the 2014 Lugano criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). The response was cumulative for each timepoint; a participant was considered a responder if their first response occurred up to the end of that timepoint.
Measured: 6, 12, 18, and 24 months after first dose of study intervention
Duration of Response (DOR)
DOR was defined for participants with CR or PR as the time from the date of first documentation of response (CR or PR) to date of the first documentation of PD or death. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease, PR as the regression of measurable disease and no new sites, and PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT), PR as partial metabolic response (according to PET-CT) and partial remission (according to CT), and PD as a progressive metabolic response (according to PET-CT) and progressive disease (according to CT). Results are reported as months.
Measured: Up to 2 years
Overall Survival (OS)
OS was the time from first dose to death (death date - treatment start date + 1). Participants without documented death were censored at their last known alive date (last known alive date - treatment start date + 1). Results reported as months.
Measured: Up to 2 years
Lymph Node Response Rate (LNRR)
LNRR was calculated as the percentage of participants achieving ≥50% decrease in the sum of the product of the diameters of target lymph nodes. The confidence interval for LNRR was calculated only for participants who had at least 1 nodal target lesion, using the Clopper-Pearson exact method for binomial proportions. Participants whose target lesions were all extranodal were excluded from this analysis.
Measured: 14 months
Time To First Response (TTFR)
For participants with CR or PR, TTFR was defined as the time from first dose of study intervention to time of first CR or PR and was calculated as: the date of first CR or PR - randomization date + 1. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). Results are reported as months.
Measured: Up to 14 months
Time To Treatment Failure (TTF)
TTF was calculated as the time from first dose of study treatment to discontinuation for any reason (discontinuation date - treatment start date + 1). Participants who were still ongoing treatment at time of data cut were censored (last dose date - treatment start date + 1). Results reported as months.
Measured: Up to 2 years
ORR According to 2014 Lugano Criteria
ORR was defined as the percentage of participants achieving a CR or PR and was assessed using the 2014 Lugano criteria. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT).
Measured: Up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start24 Sep 2019
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Indolent Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- SecuraBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038359
- Sponsor's protocol ID
- VS-0145-229
- Other IDs
- 2019-001381-14, 2019
- Acronym
- TEMPO
- Status last verified
- Sep 2024
- First submitted
- 10 Jul 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma (iNHL)
- ClinicalTrials.gov ID
- NCT04038359
- Acronym / sponsor ID
- TEMPO / VS-0145-229
- Conditions
- Indolent Non-Hodgkin Lymphoma
- Keywords
- PI3K Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.
Detailed description
This was a Phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in participants with relapsed or refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who have received at least 1 prior systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duvelisib, Continuous and Intermittent Dosing | Experimental | Drug: DuvelisibDuvelisib 25 milligrams (mg) twice daily (BID) continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on for each subsequent 4-week cycle. |
| Duvelisib, Intermittent Dosing | Experimental | Drug: DuvelisibDuvelisib 25 mg BID dosed 2 weeks on and 2 weeks off. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuvelisibAlso: Copiktra, VS-0145, IPI-145Phosphoinositide 3-kinase (PI3K) inhibitor | Drug | Duvelisib, Continuous and Intermittent Dosing, Duvelisib, Intermittent Dosing |
Primary outcome
Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria
Time frame: Up to 14 months
ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites.
8 secondary outcomes
Progression-free Survival (PFS)
Time frame: Up to 2 years
ORR At Specific Timepoints
Time frame: 6, 12, 18, and 24 months after first dose of study intervention
Duration of Response (DOR)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Lymph Node Response Rate (LNRR)
Time frame: 14 months
Time To First Response (TTFR)
Time frame: Up to 14 months
Time To Treatment Failure (TTF)
Time frame: Up to 2 years
ORR According to 2014 Lugano Criteria
Time frame: Up to 14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duvelisib in people with Indolent Non-Hodgkin Lymphoma, run by SecuraBio at 28 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Italy, South Korea, Poland, Russia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria (time frame: Up to 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.