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

Sponsor
SecuraBio (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04038359
Collaborator
(none)
102
Enrollment
40
Locations
2
Arms
58.2
Anticipated Duration (Months)
2.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Sep 24, 2019
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
Jul 29, 2024

Arms and Interventions

Arm Intervention/Treatment
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 cycles.

Drug: Duvelisib
PI3K Inhibitor
Other Names:
  • Copiktra, VS-0145

    		•
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ORR (Objective Response Rate) [36 months]

      Proportion of subjects achieving a CR or PR will be estimated as per IWG Criteria.

    Secondary Outcome Measures

    1. PFS (Progression Free Survival) [5 years]

      From time of first dose of study intervention to PD or death.

    2. ORR (Objective Response Rate) [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 Lugano Criteria

    3. DOR (Duration of Response) [5 years]

      From the time of first response to PD using KM methods.

    4. OS (Overall Survival) [5 years]

      From time of first dose of study intervention to death.

    5. LNRR (Lymph Node Response Rate) [36 months]

      LNRR will be calculated as the proportion of subjects achieving ≥ 50% decrease in the SPD of target lymph nodes.

    6. TTFR (Time To First Relapse) [36 months]

      From the time of first dose of study intervention to time of first CR or PR.

    7. Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 [36 months]

      From the time of screening to the end of Safety Follow-Up period of the study.

    8. Peak Plasma Concentration (Cmax) [36 months]

    9. TTF (Time To Treatment Failure) [5 years]

      From first dose of study intervention until discontinuation for any reason and will be summarized using KM methods.

    10. Area under the plasma concentration versus time curve (AUC) [36 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 George Washington University Washington District of Columbia United States 20052
    2 Florida Cancer Specialists - Fort Myers Fort Myers Florida United States 33901
    3 Florida Cancer Specialists $ Research Institute - Lecanto Lecanto Florida United States 34461
    4 Mid-Florida Cancer Centers Orange City Florida United States 32763
    5 Florida Cancer Specialists - Panhandle Tallahassee Florida United States 32308
    6 Florida Cancer Specialists - West Palm Beach West Palm Beach Florida United States 33401
    7 Robert H. Lurie Comprehensive Cancer Center Chicago Illinois United States 60611
    8 St. Agnes Cancer Institute Baltimore Maryland United States 21229
    9 Research Medical Center Kansas City Missouri United States 64132
    10 Nebraska Cancer Specialists Omaha Nebraska United States 68114
    11 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89169
    12 Novant Health Cancer Specialists - Charlotte Charlotte North Carolina United States 28204
    13 Greenville Health System Cancer Institute Greenville South Carolina United States 29615
    14 Tennessee Oncology Nashville Tennessee United States 37203
    15 Baylor Scott and White Research Institute - Hematology/Oncology Temple Texas United States 76508
    16 FN Hradec Kralove Hradec Králové Czechia 500 05
    17 Fakultni nemocnice Ostrava Ostrava - Poruba Czechia 708 52
    18 Vseobecna fakultni nemocnice v Praze Praha 2 Czechia 128 08
    19 Evangelisches Klinikum Bethel Bielefeld Germany 33611
    20 IRCCS IRST - Oncology Meldola Forli Italy 47014
    21 A.O.di Bologna Policl.S.Orsola Bologna Italy 40138
    22 Ospedale San Raffaele Milano Italy 20132
    23 Ieo, Irccs Milano Italy 20141
    24 Azienda Ospedaliera Santa Maria di Terni Terni Italy 05100
    25 Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fon Varese Italy 21100
    26 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13620
    27 Seoul National University Hospital Seoul Korea, Republic of 03080
    28 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    29 Asan Medical Center - Oncology Seoul Korea, Republic of 05505
    30 Samsung Medical Center - Hematology-Oncology Seoul Korea, Republic of 06351
    31 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    32 Korea University Guro Hospital - Medical Oncology Seoul Korea, Republic of 08308
    33 Wojewódzki Szpital Specjalistyczny sp.z o.o. Slupsk Pomorskie Poland 76-200
    34 Silesian Healthy Blood Clinic Chorzów Poland 41-500
    35 Gabinety Lekarskie Hema Lublin Poland 20-601
    36 Examen Sp. z o.o. Skórzewo Poland 60-185
    37 City Clinical Hospital n.a. Botkin Moscow Russian Federation 125284
    38 Leningrad Regional Clinical Hospital Sankt-Peterburg Russian Federation 194291
    39 Cruk Clinical Trials Unit Glasgow United Kingdom G12 0YN
    40 Christie Hospital NHS Foundation Trust Manchester United Kingdom M20 4BX

    Sponsors and Collaborators

    • SecuraBio

    Investigators

    • Study Director: David Cohan, MD, SecuraBio Chief Medical Officer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SecuraBio
    ClinicalTrials.gov Identifier:
    NCT04038359
    Other Study ID Numbers:
    • VS-0145-229
    First Posted:
    Jul 30, 2019
    Last Update Posted:
    May 18, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by SecuraBio
    PI3K Inhibitor
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin

    Study Results

    No Results Posted as of May 18, 2021