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

Primary Purpose

Indolent Non-hodgkin Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Duvelisib
Sponsored by
SecuraBio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Indolent Non-hodgkin Lymphoma focused on measuring PI3K Inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, and at least 1 bi-dimensionally measurable lesion ≥ 1.5 cm (which has not been previously irradiated), according to 2007 revised IWG criteria

  • 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
    • Serum creatinine < 2.0 mg/dL (197 µmol/L)
    • 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 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); 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.

Sites / Locations

  • George Washington University
  • Florida Cancer Specialists - Fort Myers
  • Florida Cancer Specialists & Research Institute - Lecanto
  • Mid-Florida Cancer Centers
  • Florida Cancer Specialists - Panhandle
  • Florida Cancer Specialists - West Palm Beach
  • Robert H. Lurie Comprehensive Cancer Center
  • St. Agnes Cancer Institute
  • Research Medical Center
  • Nebraska Cancer Specialists
  • Comprehensive Cancer Centers of Nevada
  • Novant Health Cancer Specialists - Charlotte
  • Greenville Health System Cancer Institute
  • Tennessee Oncology
  • Baylor Scott and White Research Institute - Hematology/Oncology
  • FN Hradec Kralove
  • Fakultni nemocnice Ostrava
  • Vseobecna fakultni nemocnice v Praze
  • Evangelisches Klinikum Bethel
  • IRCCS IRST - Oncology
  • A.O.di Bologna Policl.S.Orsola
  • Ospedale San Raffaele
  • Ieo, Irccs
  • Azienda Ospedaliera Santa Maria di Terni
  • Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fon
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center - Oncology
  • Samsung Medical Center - Hematology-Oncology
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Korea University Guro Hospital - Medical Oncology
  • Wojewódzki Szpital Specjalistyczny sp.z o.o.
  • Silesian Healthy Blood Clinic
  • Gabinety Lekarskie Hema
  • Examen Sp. z o.o.
  • City Clinical Hospital n.a. Botkin
  • Leningrad Regional Clinical Hospital
  • Cruk Clinical Trials Unit
  • Christie Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Duvelisib, Continuous and Intermittent Dosing

Duvelisib, Intermittent Dosing

Arm Description

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 cycles.

Duvelisib 25 mg BID dosed two weeks on and two weeks off.

Outcomes

Primary Outcome Measures

ORR (Objective Response Rate)
Proportion of subjects achieving a CR or PR will be estimated as per IWG Criteria.

Secondary Outcome Measures

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

Full Information

First Posted
July 10, 2019
Last Updated
August 8, 2023
Sponsor
SecuraBio
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1. Study Identification

Unique Protocol Identification Number
NCT04038359
Brief Title
A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma. (TEMPO)
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) (TEMPO)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SecuraBio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent Non-hodgkin Lymphoma
Keywords
PI3K Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duvelisib, Continuous and Intermittent Dosing
Arm Type
Experimental
Arm Description
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 cycles.
Arm Title
Duvelisib, Intermittent Dosing
Arm Type
Experimental
Arm Description
Duvelisib 25 mg BID dosed two weeks on and two weeks off.
Intervention Type
Drug
Intervention Name(s)
Duvelisib
Other Intervention Name(s)
Copiktra, VS-0145
Intervention Description
PI3K Inhibitor
Primary Outcome Measure Information:
Title
ORR (Objective Response Rate)
Description
Proportion of subjects achieving a CR or PR will be estimated as per IWG Criteria.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
PFS (Progression Free Survival)
Description
From time of first dose of study intervention to PD or death.
Time Frame
5 years
Title
ORR (Objective Response Rate)
Description
Proportion of subjects achieving a CR or PR will be estimated as per Lugano Criteria
Time Frame
ORR estimated at 6, 12, 18, and 24 months after first dose of study intervention.
Title
DOR (Duration of Response)
Description
From the time of first response to PD using KM methods.
Time Frame
5 years
Title
OS (Overall Survival)
Description
From time of first dose of study intervention to death.
Time Frame
5 years
Title
LNRR (Lymph Node Response Rate)
Description
LNRR will be calculated as the proportion of subjects achieving ≥ 50% decrease in the SPD of target lymph nodes.
Time Frame
36 months
Title
TTFR (Time To First Relapse)
Description
From the time of first dose of study intervention to time of first CR or PR.
Time Frame
36 months
Title
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Description
From the time of screening to the end of Safety Follow-Up period of the study.
Time Frame
36 months
Title
Peak Plasma Concentration (Cmax)
Time Frame
36 months
Title
TTF (Time To Treatment Failure)
Description
From first dose of study intervention until discontinuation for any reason and will be summarized using KM methods.
Time Frame
5 years
Title
Area under the plasma concentration versus time curve (AUC)
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, and at least 1 bi-dimensionally measurable lesion ≥ 1.5 cm (which has not been previously irradiated), according to 2007 revised IWG criteria 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 Serum creatinine < 2.0 mg/dL (197 µmol/L) 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 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); 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.
Facility Information:
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States
Facility Name
Florida Cancer Specialists - Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute - Lecanto
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Mid-Florida Cancer Centers
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Florida Cancer Specialists - Panhandle
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Florida Cancer Specialists - West Palm Beach
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
St. Agnes Cancer Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Novant Health Cancer Specialists - Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Greenville Health System Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor Scott and White Research Institute - Hematology/Oncology
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
FN Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Evangelisches Klinikum Bethel
City
Bielefeld
ZIP/Postal Code
33611
Country
Germany
Facility Name
IRCCS IRST - Oncology
City
Meldola
State/Province
Forli
ZIP/Postal Code
47014
Country
Italy
Facility Name
A.O.di Bologna Policl.S.Orsola
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ieo, Irccs
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria di Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fon
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center - Oncology
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center - Hematology-Oncology
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital - Medical Oncology
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Wojewódzki Szpital Specjalistyczny sp.z o.o.
City
Slupsk
State/Province
Pomorskie
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Silesian Healthy Blood Clinic
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Gabinety Lekarskie Hema
City
Lublin
ZIP/Postal Code
20-601
Country
Poland
Facility Name
Examen Sp. z o.o.
City
Skórzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
City Clinical Hospital n.a. Botkin
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
Sankt-Peterburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Cruk Clinical Trials Unit
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Christie Hospital NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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