Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516605-23-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will evaluate the progression-free survival benefit of duvelisib monotherapy as compared to investigator's choice of gemcitabine or bendamustine in participants with relapsed/refractory nodal T cell lymphoma with TFH phenotype.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duvelisib | Experimental | Duvelisib will be administered orally twice daily (BID) in 28-day cycles. |
|
| Gemcitabine or Bendamustine | Active Comparator | Participants will receive the investigator's choice of gemcitabine or bendamustine. The regimen to be used after randomization must be selected by the investigator prior to randomization. Gemcitabine will be administered intravenously (IV) on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. Bendamustine will be administered IV on days 1 and 2 of each 21-day cycle for up to 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duvelisib | Drug | oral capsules |
| |
| Gemcitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC) | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 3 years | |
| PFS as assessed by the investigator | Up to 3 years | |
| Objective Response Rate (ORR) as assessed by the IRC |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined criteria apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ohad Bentur | Contact | (702) 254-0011 | TerzoMM@securabio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Gent (UZ Gent) | Recruiting | Ghent | 9000 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
solution for intravenous infusion |
|
| Bendamustine | Drug | solution for intravenous infusion |
|
| Up to 3 years |
| Complete Response Rate (CRR) as assessed by the IRC | Up to 3 years |
| Duration of Response (DOR) as assessed by the IRC | Up to 3 years |
| Proportion of participants who proceed to Stem Cell Transplantation (SCT) | Up to 3 years |
| Investigator-assessed PFS in participants who proceed to SCT | Up to 3 years |
| Number of participants with Adverse Events (AEs) | Up to 3 years |
| Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score | Up to 3 years |
| QoL: EQ5D Score | Up to 3 years |
| QoL: QLQ-NHL-HG29 Score | Up to 3 years |
| Concentration of Duvelisib and its Metabolites in Blood | Day 1 of Cycle 1 and Cycle 2 (predose and 60 minutes postdose) |
| UZ Leuven - Gasthuisberg Campus | Recruiting | Leuven | 3000 | Belgium |
|
| Vseobecna fakultni nemocnice | Recruiting | Prague | 128 08 | Czechia |
|
| Aarhus University Hospital | Recruiting | Aarhus | DK-8200 | Denmark |
|
| Rigshospitalet Copenhagen | Recruiting | Copenhagen | DK-2100 | Denmark |
|
| Odense Hospital | Recruiting | Odense | DK-5000 | Denmark |
|
| UNICANCER - Centre Henri-Becquerel | Recruiting | Rouen | Normandy | 76038 Cedex 1 | France |
|
| Institut Gustave Roussy | Recruiting | Villejuif | Vaillant | 94805 | France |
|
| CHU Cote de Nacre | Recruiting | Caen | 14033 | France |
|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
|
| CHU Montpellier | Recruiting | Montpellier | 34295 | France |
|
| CHU Nantes | Recruiting | Nantes | 44093 | France |
|
| Hopital Pitie Salpetriere | Recruiting | Paris | 75019 | France |
|
| CHU Bordeaux | Recruiting | Pessac | 33604 | France |
|
| Centre Hospitalier Lyon Sud | Recruiting | Pierre-Bénite | 69310 | France |
|
| CHU PONTCHAILLOU-Haematology | Recruiting | Rennes | France |
|
| Institut Curie Paris | Recruiting | Saint-Cloud | 92210 | France |
|
| Evangelisches Krankenhaus Essen-Werden | Recruiting | Essen | 45239 | Germany |
|
| Universitaetsmedizin Goettingen (UMG) - Klinik fuer Haematologie und Medizinische Onkologie | Recruiting | Goettigen | 37075 | Germany |
|
| Universitaetsklinikum Halle (Saale) | Recruiting | Halle | 06120 | Germany |
|
| Universitaetsklinikum Leipzig- Klinik und Poliklinik fuer Haematologie und Zelltherapie | Recruiting | Leipzig | 04103 | Germany |
|
| Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria | Recruiting | Alessandria | 15121 | Italy |
|
| Asst Papa Giovanni Xxiii Uo Ematologia | Recruiting | Bergamo | 24127 | Italy |
|
| Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
|
| Ematologia Oncologia Instituto Pascale | Recruiting | Naples | Italy |
|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | 00168 | Italy |
|
| Amsterdam UMC location AMC | Recruiting | Amsterdam | 1105 AZ | Netherlands |
|
| Leiden University Medical Center (LUMC) | Recruiting | Leiden | 2333 ZA | Netherlands |
|
| Erasmus University Medical Center | Recruiting | Rotterdam | 3015GD | Netherlands |
|
| Uniwersyteckie Centrum Kliniczne Oddzial Hematologii i Transplantologii | Recruiting | Gdansk | 80-214 | Poland |
|
| Pratia Centrum Medyczne Krakow | Recruiting | Krakow | 30-727 | Poland |
|
| Instytut Hematologii i Transfuzjologii | Recruiting | Warsaw | 02-776 | Poland |
|
| Narodowy Instytut Onkologii im. Marii Skłodowskiej - Curie | Recruiting | Warsaw | 02-781 | Poland |
|
| ICO Hospitalet (Hospital Duran i Reynals) | Recruiting | Barcelona | 08908 | Spain |
|
| Hospital Universitario Fundacion Jimenez Diaz | Recruiting | Madrid | 37007 | Spain |
|
| Hospital Clinico Universitario de Salamanca | Recruiting | Salamanca | 58182 | Spain |
|
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | Spain |
|
| The Royal Marsden NHS Foundation Trust | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
|
| Beatson West of Scotland Cancer Centre | Recruiting | Glasgow | G12 0YN | United Kingdom |
|
| University Hospitals of Leicester NHS Trust | Recruiting | Leicester | LE1 5WW | United Kingdom |
|
| UCLH NHS Foundation Trust | Recruiting | London | NW1 2PG | United Kingdom |
|
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
|
| Nottingham University Hospitals NHS Trust | Recruiting | Nottingham | NG5 1PB | United Kingdom |
|
| Oxford University Hospitals NHS Foundation Trust | Recruiting | Oxford | OX3 7LE | United Kingdom |
|
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D012008 | Recurrence |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D007119 | Immunoblastic Lymphadenopathy |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D000072281 | Lymphadenopathy |
Not provided
Not provided
| ID | Term |
|---|---|
| C586691 | duvelisib |
| D000093542 | Gemcitabine |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided