Clinical trial • Phase III • Oncology

PIRTOBRUTINIB for Chronic lymphocytic leukemia | Small lymphocytic lymphoma

Phase III trial of PIRTOBRUTINIB for Chronic lymphocytic leukemia | Small lymphocytic lymphoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Chronic lymphocytic leukemia | Small lymphocytic lymphoma
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
03-04-2024
First CTIS Authorization Date
26-04-2024

Trial design

Randomised, open-label, arm a: pirtobrutinib (pirtobrutinib) — oral (max daily dose: 200 mg as provided in product info). arm b (comparator): ibrutinib (ibrutinib) — oral (max daily dose: 420 mg as provided in product info).-controlled Phase III trial in Austria, Hungary, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm A: Pirtobrutinib (PIRTOBRUTINIB) — oral (max daily dose: 200 mg as provided in product info). Arm B (comparator): Ibrutinib (IBRUTINIB) — oral (max daily dose: 420 mg as provided in product info).
Target Sample Size
362

Eligibility

Recruits 362 adults.

Inclusion criteria

  • {"criterion_text":"- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria.\n- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.\n- Adequate organ function • Platelets greater than or equal to (≥)50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis, • Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis • Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis • Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min).\n- Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 – Must have deletion of 17p as determined by FISH testing performed in a CLIA, ISO/IEC, CAP, or other similarly certified laboratory as per local guidelines, including, but not limited to, IVDR compliance as applicable."}

Exclusion criteria

  • {"criterion_text":"- Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment.\n- Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments.\n- Ongoing inflammatory bowel disease.\n- Part 1: Prior exposure to BTK inhibitor (covalent or noncovalent). Part 2: Prior therapy for CLL\n- Concurrent use of investigational agent or anticancer therapy except hormonal therapy.\n- Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.\n- Use of > 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug.\n- Vaccination with a live vaccine within 28 days prior to randomization.\n- Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.\n- Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib.\n- Known or suspected central nervous system (CNS) involvement.\n- A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease.\n- Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP]).\n- Significant cardiovascular disease including ejection fraction < 40% and any grade ongoing atrial fibrillation or atrial flutter.\n- Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests.\n- Active cytomegalovirus (CMV) infection.\n- Active uncontrolled systemic bacterial, viral, or fungal infection.\n- Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part 1 and Part 2: Primary endpoint: Overall response rate (ORR) as assessed by independent review committee (IRC) per iwCLL 2018 criteria. ORR is defined as the proportion of patients who achieve a BOR of CR, CRi, nPR, or PR at or before the initiation of subsequent anticancer therapy.","definition_or_measurement_approach":"Overall response rate (ORR) as assessed by independent review committee (IRC) per iwCLL 2018 criteria; ORR is defined as the proportion of patients who achieve a best overall response (BOR) of CR, CRi, nPR, or PR at or before initiation of subsequent anticancer therapy."}

Recruitment

Planned Sample Size
362
Recruitment Window Months
69
Consent Approach
Subject information and informed consent forms are provided; multilingual ICF documents available (examples in the dossier include English, French, German, Italian, Spanish, Polish, Hungarian, Dutch). Specifics on who provides consent (e.g., parental consent) or assent procedures are not specified in the available record.

Geography

Total Number Of Sites
55
Total Number Of Participants
377

Austria

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
06-05-2024
Processing Time Days
21
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department Name
III. Medizinische Abteilung
Contact Person Name
Thomas Noesslinger
Contact Person Email
thomas.noesslinger@oegk.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Interne I: Medizinische Onkologie und Hämatologie
Contact Person Name
Manuel Orlinger

Hungary

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
26-04-2024
Processing Time Days
11
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
University Of Debrecen
Department Name
Belgyógyászati Klinika, B épület. Hematológia
Contact Person Name
Árpád Illés
Contact Person Email
illesarpaddr@gmail.com
Site Name
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Department Name
Haematológiai és Haemosztazeológiai Osztály
Contact Person Name
Márk Plander
Contact Person Email
planderm@yahoo.com

Germany

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
03-05-2024
Processing Time Days
18
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Medizinische Klinik und Poliklinik 1
Contact Person Name
Johannes Schetelig
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Department Name
Hematology and Oncology
Contact Person Name
Lutz Jacobasch
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik fuer Innere Medizin III
Contact Person Name
Stephan Stilgenbauer

Poland

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
20-05-2024
Processing Time Days
35
Number Of Sites
8
Number Of Participants
160

Sites

Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Contact Person Name
Sebastian Grosicki
Contact Person Email
sgrosicki@wp.pl
Site Name
Pratia S.A.
Department Name
Pratia MCM Kraków
Contact Person Name
Wojciech Jurczak
Contact Person Email
wojciech.jurczak@pratia.com
Site Name
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Department Name
Oddział Onkologii Klinicznej
Contact Person Name
Piotr Centkowski
Contact Person Email
pcentek@wp.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
Contact Person Name
Tomasz Wrobel
Contact Person Email
tomasz_wrobel@wp.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Klinika Hematoonkologii i Transplantacji Szpiku
Contact Person Name
Waldemar Tomczak
Contact Person Email
Waldemar.m.tomczak@gmail.com
Site Name
Aidport Sp. z o.o.
Contact Person Name
Michal Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Hematologii
Contact Person Name
Marta Sobas
Contact Person Email
marta.sobas@cm.umk.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologi
Contact Person Name
Monika Szarejko
Contact Person Email
monasza1@gumed.edu.pl

Italy

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
03-05-2024
Processing Time Days
18
Number Of Sites
6
Number Of Participants
16

Sites

Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
SC Ematologia
Contact Person Name
Fiorella Ilariucci
Contact Person Email
fiorella.ilariucci@ausl.re.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dipartimento di Scienze Mediche e Chirurgiche
Contact Person Name
Pier Luigi Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia medica
Contact Person Name
Gerardo Musuraca
Contact Person Email
gerardo.musuraca@irst.emr.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di oncoematologia
Contact Person Name
Paolo Ghia
Contact Person Email
ghia.paolo@hsr.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Onco-Ematologia
Contact Person Name
Enrico Derenzini
Contact Person Email
enrico.derenzini@ieo.it
Site Name
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
Department Name
SCDU Ematologia
Contact Person Name
Gioacchino Catania

Belgium

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
07-05-2024
Processing Time Days
22
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Vitaz
Department Name
Hematology
Contact Person Name
Vanessa Van Hende
Contact Person Email
vanessa.vanhende@vitaz.be
Site Name
UZ Leuven
Department Name
Hematology
Contact Person Name
Ann Janssens
Contact Person Email
ann.janssens@uzleuven.be

Czechia

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
02-05-2024
Processing Time Days
17
Number Of Sites
6
Number Of Participants
74

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Interní hematologická a onkologická klinika
Contact Person Name
Anna Panovská
Contact Person Email
panovska.anna@fnbrno.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. interní klinika klinika hematologie 1. LF a VFNU
Contact Person Name
Marek Trněný
Contact Person Email
marek.trneny@vfn.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. interní hematologická klinika
Contact Person Name
Martin Šimkovič
Contact Person Email
martin.simkovic@fnhk.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Hematologická klinika
Contact Person Name
Jan Novák
Contact Person Email
jan.novak@fnkv.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie FNO a LF OU
Contact Person Name
Jana Mihalyová
Contact Person Email
jana.mihalyova@fno.cz
Site Name
Fakultni Nemocnice Plzen
Department Name
Hematologicko-onkologické oddělení
Contact Person Name
Daniel Lysák
Contact Person Email
lysak@fnplzen.cz

Spain

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
26-04-2024
Processing Time Days
11
Number Of Sites
16
Number Of Participants
56

Sites

Site Name
Hospital Germans Trias I Pujol
Department Name
General Practice
Contact Person Name
David Quintela Vilchez
Contact Person Email
dquintelav@iconcologia.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Contact Person Name
Francesc Bosch Albareda
Contact Person Email
fbosch@vhio.net
Site Name
Hospital Costa Del Sol
Department Name
Hematology
Contact Person Name
Maria Angeles Medina Perez
Contact Person Email
amedinaperez@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Contact Person Name
Javier Lopez Jimenez
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Hematology
Contact Person Name
Jose Antonio García Vela
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Contact Person Name
Lucrecia Yanez San Segundo
Contact Person Email
lucrecia.yanez@scsalud.es
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Hematology
Contact Person Name
Josep Maria Roncero Vidal
Contact Person Email
jroncero@iconcologia.net
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Contact Person Name
Eva Gonzalez Barca
Contact Person Email
e.gonzalez@iconcologia.net
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Hematology
Contact Person Name
Alicia Rodriguez Fernandez
Site Name
Hospital Universitario Infanta Leonor
Department Name
Hematology
Contact Person Name
Jose Angel Hernandez Rivas
Contact Person Email
jahernandezr@salud.madrid.org
Site Name
Hospital Universitario De Navarra
Department Name
Hematology
Contact Person Name
Jose María Arguiñano Perez
Contact Person Email
jm.arguinano.perez@navarra.es
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Hematology
Contact Person Name
Alexia Suarez Cabrera
Contact Person Email
asuacab@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Hematology
Contact Person Name
Miguel Arguello De Tomas
Contact Person Email
marguello@santpau.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Contact Person Name
Fatima de la Cruz Vicente
Contact Person Email
fatimadelacruzv@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Hematology
Contact Person Name
Rocio Figueroa
Contact Person Email
mfmora@unav.es
Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Contact Person Name
Pablo Javier Mozas Fernandez
Contact Person Email
mozas@clinic.cat

France

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
26-04-2024
Processing Time Days
11
Number Of Sites
10
Number Of Participants
47

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hématologie
Contact Person Name
Anne Lok
Contact Person Email
anne.lok@chu-nantes.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hématologie clinique et thérapie cellulaire
Contact Person Name
Natalia Dmytruk
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hématologie clinique
Contact Person Name
Sophie De Guibert
Site Name
Hopital Universitaire Pitie Salpetriere
Department Name
Hématologie clinique
Contact Person Name
Damien Roos-Weil
Contact Person Email
damien.roosweil@aphp.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hématologie et thérapie cellulaire
Contact Person Name
Caroline Dartigeas
Contact Person Email
c.dartigeas@chu-tours.fr
Site Name
Centre Henri Becquerel
Department Name
Hématologie
Contact Person Name
Stéphane Leprêtre
Site Name
Centre Antoine Lacassagne
Department Name
Oncologie médicale
Contact Person Name
Luca Inchiappa
Site Name
Centre Hospitalier Lyon Sud
Department Name
Hématologie clinique
Contact Person Name
Emmanuelle Ferrant
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Onco-hématologie
Contact Person Name
Jessie Bourcier
Contact Person Email
jessie.bourcier@ght85.fr
Site Name
Centre Hospitalier Le Mans
Department Name
Onco-hématologie
Contact Person Name
Kamel Laribi
Contact Person Email
klaribi@ch-lemans.fr

Sponsor

Primary sponsor

Full Name
Loxo Oncology Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
IQVIA Limited
Responsibilities
Sponsor duties codes: 1,12,13,2,3,5,6
Name
Perceptive Eclinical Limited
Responsibilities
Medical Imaging Analysis

Third parties

  • {"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"Patient travel assistance","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term storage for samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code: 4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Molecular Pathology Laboratory Network Inc.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eli Lilly & Co.","duties_or_roles":"code: 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"Medical Imaging Analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duties codes: 1,12,13,2,3,5,6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
PIRTOBRUTINIB
Active Substance
PIRTOBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Frequency
daily
Maximum Dose
200 mg
Investigational Product Name
IBRUTINIB
Active Substance
IBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Frequency
daily
Maximum Dose
420 mg

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