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|Monoclonal antibody

Key dates

Initial CTIS Submission Date
19-04-2024
First CTIS Authorization Date
28-05-2024

Trial design

Randomised, open-label, bendamustine plus rituximab (br) — bendamustine (intravenous; dose unit mg/m2; max daily dose amount recorded 90 mg/m2) plus rituximab (intravenous; dose unit mg/m2; max daily dose amount recorded 500 mg/m2). schedule details not specified in the ctis extract.-controlled, crossover Phase III trial across 47 sites in Hungary, Spain, Bulgaria and others.

Randomised
Yes
Open Label
Yes
Comparator
Bendamustine plus Rituximab (BR) — Bendamustine (intravenous; dose unit mg/m2; max daily dose amount recorded 90 mg/m2) plus Rituximab (intravenous; dose unit mg/m2; max daily dose amount recorded 500 mg/m2). Schedule details not specified in the CTIS extract.
Crossover
Yes
Target Sample Size
116

Eligibility

Recruits 116 The CTIS record flags isVulnerablePopulationSelected = true. All participants must be adults (Age 18 years or older). Informed consent is documented via multiple subject information and informed consent forms (ICFs) including country/language-specific ICFs and specific ICFs for crossover, pregnant partner, treatment beyond PD, and optional genetic testing. No assent procedures for minors are described in the CTIS record..

Vulnerable Population
The CTIS record flags isVulnerablePopulationSelected = true. All participants must be adults (Age 18 years or older). Informed consent is documented via multiple subject information and informed consent forms (ICFs) including country/language-specific ICFs and specific ICFs for crossover, pregnant partner, treatment beyond PD, and optional genetic testing. No assent procedures for minors are described in the CTIS record.

Inclusion criteria

  • {"criterion_text":"- Age 18 years or older per local regulations at time of enrollment. Type of Patient and Disease Characteristics"}
  • {"criterion_text":"- Confirmed diagnosis by redacted local laboratory report of CLL/SLL as defined by iwCLL 2018 criteria including the following: a) B-cells co-express CD5 and CD23; express at least one B-cell antigen (CD19 or CD20) and be either κ or λ light-chain restricted. Atypical cases may be considered with Sponsor approval. b) ≥ 5 × 109 B lymphocytes/L (5000/μL) in the peripheral blood for CLL patients. For SLL patients, <5 × 109 B cells/L (5000/μL) in the peripheral blood is allowed. c) Prolymphocytes may comprise ≤ 55% of blood lymphocytes (for CLL patients)."}
  • {"criterion_text":"- A requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy such that at least 1 of the following should be met: a) Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (such as hemoglobin < 10 g/dL) and/or thrombocytopenia (such as platelets ≤ 100 × 109/L). b) Massive (i.e., spleen edge ≥ 6 cm below the left costal margin) or progressive or symptomatic splenomegaly (> 13 cm). c) Massive nodes (i.e., ≥ 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy. d) Progressive lymphocytosis with an increase of > 50% over a 2-month period, or lymphocyte doubling time < 6 months. Factors contributing to lymphocytosis other than CLL/SLL (e.g., infections, steroid administration) should be excluded. e) Autoimmune complications including anemia or thrombocytopenia poorly responsive to corticosteroids. f) Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine). g) Disease-related symptoms (also known as B-symptoms) as defined by any of the following: i) Unintentional weight loss ≥ 10% within the previous 6 months. ii) Significant fatigue (i.e., Eastern Cooperative Oncology Group [ECOG] performance scale 2 or worse; cannot work or unable to perform usual activities). iii) Fevers ≥ 100.5°F or 38.0°C for 2 or more weeks without evidence of infection. iv) Night sweats for ≥ 1 month without evidence of infection."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) 0-2."}
  • {"criterion_text":"- Must have adequate organ function, as defined below. Results from the most recent laboratory tests prior to enrollment will be used for eligibility."}
  • {"criterion_text":"- Patients are required the have had the following washout periods prior to planned C1D1: a) Palliative limited field radiation: 7 days b) Broad field radiation (≥ 30% of bone marrow or whole brain radiotherapy): 28 days Contraception"}
  • {"criterion_text":"- Willingness women of childbearing potential (WOCBP), and their partners, to both observe barrier method and highly effective birth control methods as outlined in Section 10.2 (Appendix 2; and below) for the duration of treatment and for 1 month following the last dose of pirtobrutinib or 12 months after the last dose of rituximab, whichever is later. WOCBP are defined as women following menarche, and who are not postmenopausal (or 2 years of non-therapy-induced amenorrhea, or surgically sterile). WOCBP must utilize 2 effective contraception methods with at least 1 form of highly effective contraception method as outlined below. In addition, male partners must use a barrier method (condoms) for the duration of treatment and for 1 month following the last dose of study treatment or 12 months after the last dose of rituximab. Male patients enrolled in Arm B with partners who are WOCBP must use a barrier method (condoms) and their partner must also use a highly effective form of contraception as listed below for the duration of treatment and for 12 months after the last dose of rituximab. For further please refer to Protocol."}

Exclusion criteria

  • {"criterion_text":"- Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin lymphoma at any time preceding enrollment."}
  • {"criterion_text":"- Presence of 17p deletion by fluorescence in-situ hybridization (FISH) (refer to Section 8.10.2)"}
  • {"criterion_text":"- Known or suspected history of central nervous system (CNS) involvement by CLL/SLL."}
  • {"criterion_text":"- Active second malignancy. Patients with treated second malignancy who are in remission with life expectancy > 2 years and with documented Sponsor approval are eligible. Examples include: a) Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease. b) Adequately treated cervical carcinoma in situ without current evidence of disease. c) Localized (e.g., lymph node negative) breast cancer treated with curative intent with no evidence of active disease present for more than 3 years and receiving adjuvant hormonal therapy. d) Localized prostate cancer undergoing active surveillance. e) History of treated and cured Hodgkin's disease or NHL within 5 years from diagnosis."}
  • {"criterion_text":"- Major surgery, within 4 weeks of planned start of study treatment."}
  • {"criterion_text":"- A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic, that, in the opinion of the Investigator, would adversely affect the patient's participation in this study or interpretation of study outcomes."}
  • {"criterion_text":"- Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP]) not on a stable regimen and dose for at least 4 weeks prior to study enrollment"}
  • {"criterion_text":"- Significant cardiovascular disease defined as any of the following: a) Unstable angina or acute coronary syndrome within the past 2 months, b) History of myocardial infarction within 3 months prior to planned start of study drug, c) Documented LVEF by any method of ≤ 40% d) ≥ Grade 3 NYHA functional classification system of heart failure, uncontrolled or symptomatic arrhythmias"}
  • {"criterion_text":"- Prolongation of the QT interval corrected (QTc) for heart rate using Fredericia's Formula (QTcF) > 470 msec on at least 2 of 3 consecutive ECGs, and mean QTcF > 470 msec on all 3 ECGs, during Screening. a) QTcF is calculated using Fredericia's Formula (QTcF = QT/(RR^0.33) b) Correction of suspected drug-induced QTcF prolongation or prolongation due to electrolyte abnormalities can be attempted at the Investigator's discretion, and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation or electrolyte supplementation. c) Correction of QTc for underlying bundle branch block (BBB) permissible."}
  • {"criterion_text":"- Hepatitis B or hepatitis C testing indicating active/ongoing infection based on Screening laboratory tests as defined as: a) Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B Polymerase chain reaction (PCR) evaluation before randomization. Patients who are hepatitis B PCR positive will be excluded. b) Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded. c) For optional crossover, repeat testing is not required."}
  • {"criterion_text":"- Active cytomegalovirus (CMV) infection."}
  • {"criterion_text":"- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal) or other clinically significant active disease process which in the opinion of the Investigator and Medical Monitor may pose a risk for patient participation. Screening for chronic conditions is not required."}
  • {"criterion_text":"- Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count. Patients with unknown or negative status are eligible."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Assessed by IRC: PFS per iwCLL 2018 response criteria","definition_or_measurement_approach":"Assessed by Independent Review Committee (IRC) using iwCLL 2018 response criteria (PFS defined per iwCLL 2018; assessed by IRC)."}

Recruitment

Planned Sample Size
116
Recruitment Window Months
45
Consent Approach
Informed consent is obtained from participants (participants must be Age 18 years or older). Multiple subject information and informed consent forms (ICFs) and subject information sheets are provided, including country/language-specific ICFs (examples in Hungarian, Spanish, French, Polish, Portuguese, Italian, Romanian, English, Bulgarian, Czech). There are specific ICFs for crossover, pregnant partners, treatment beyond progressive disease, and optional genetic/biobank studies. Consent is provided by the participant; no assent for minors is described.

Geography

Total Number Of Sites
47
Total Number Of Participants
166

Hungary

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
643
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
University Of Debrecen
Department Name
Belgyógyászati Klinika. B épület. Hematológia
Principal Investigator Name
Árpád Illés
Principal Investigator Email
illesarpaddr@gmail.com
Contact Person Name
Árpád Illés
Contact Person Email
illesarpaddr@gmail.com
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
III. Belgyógyászat - Hematológiai Osztály
Principal Investigator Name
Mária Dömötör
Principal Investigator Email
mariadomotor@gmail.com
Contact Person Name
Mária Dömötör
Contact Person Email
mariadomotor@gmail.com
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Jósa András Oktatókórház, Hematológia
Principal Investigator Name
László Rejtő
Principal Investigator Email
lrejto@med.unideb.hu
Contact Person Name
László Rejtő
Contact Person Email
lrejto@med.unideb.hu

Spain

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
643
Number Of Sites
6
Number Of Participants
8

Sites

Site Name
Hospital Universitario Central De Asturias
Department Name
Dermatology
Principal Investigator Name
Angel Ramirez Payer
Principal Investigator Email
apayer.angel@gmail.com
Contact Person Name
Angel Ramirez Payer
Contact Person Email
apayer.angel@gmail.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Hematology
Principal Investigator Name
Jaime Perez de Oteyza
Principal Investigator Email
jperezoteyza@hmhospitales.com
Contact Person Name
Jaime Perez de Oteyza
Contact Person Email
jperezoteyza@hmhospitales.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Principal Investigator Name
Raúl Cordoba Mascuñano
Principal Investigator Email
Raul.cordoba@fjd.es
Contact Person Name
Raúl Cordoba Mascuñano
Contact Person Email
Raul.cordoba@fjd.es
Site Name
Hospital Universitario Virgen De Valme
Department Name
Hematology
Principal Investigator Name
Eduardo Rios Herranz
Principal Investigator Email
eduardo.rios.sspa@juntadeandalucia.es
Contact Person Name
Eduardo Rios Herranz
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Hematology
Principal Investigator Name
Miguel Arguello De Tomas
Principal Investigator Email
marguello@santpau.cat
Contact Person Name
Miguel Arguello De Tomas
Contact Person Email
marguello@santpau.cat
Site Name
University Hospital Virgen Del Rocio
Department Name
Hematology
Principal Investigator Name
Fátima de la Cruz
Principal Investigator Email
fatimadelacruzv@gmail.com
Contact Person Name
Fátima de la Cruz
Contact Person Email
fatimadelacruzv@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
643
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinic of clinical hematology
Principal Investigator Name
Atanas Radinoff
Principal Investigator Email
aradinoff@hotmail.com
Contact Person Name
Atanas Radinoff
Contact Person Email
aradinoff@hotmail.com
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of clinical hematology
Principal Investigator Name
Zhanet Grudeva-Popova
Principal Investigator Email
dr_grudeva@yahoo.com
Contact Person Name
Zhanet Grudeva-Popova
Contact Person Email
dr_grudeva@yahoo.com
Site Name
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Department Name
Clinic of clinical hematology
Principal Investigator Name
Tanya Yankova
Principal Investigator Email
t.yankova@hematology.bg
Contact Person Name
Tanya Yankova
Contact Person Email
t.yankova@hematology.bg
Site Name
Umbal - Prof. D-R Stoyan Kirkovich AD
Department Name
Department of Clinical Hematology, UMHAT - Prof. Dr. Stoyan Kirkovich AD, Stara Zagora
Principal Investigator Name
Maria Todorova
Principal Investigator Email
dr.maria.dtodorova@gmail.com
Contact Person Name
Maria Todorova
Contact Person Email
dr.maria.dtodorova@gmail.com

France

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
640
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Centre Hospitalier Le Mans
Department Name
Onco-hématologie
Principal Investigator Name
Kamel Laribi
Principal Investigator Email
klaribi@ch-lemans.fr
Contact Person Name
Kamel Laribi
Contact Person Email
klaribi@ch-lemans.fr

Austria

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
643
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Universitätsklinik für Innere Medizin III der PMU
Principal Investigator Name
Alexander Egle
Principal Investigator Email
a.egle@salk.at
Contact Person Name
Alexander Egle
Contact Person Email
a.egle@salk.at
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
1. Medizinische Abteilung -Zentrum für Onkologie und Hämatologie
Principal Investigator Name
Thomas Spanberger
Principal Investigator Email
Thomas.spanberger@gesundheitsverbund.at
Contact Person Name
Thomas Spanberger

Poland

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
08-02-2026
Processing Time Days
642
Number Of Sites
11
Number Of Participants
93

Sites

Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Hematologii
Principal Investigator Name
Marta Sobas
Principal Investigator Email
marta.sobas@cm.umk.pl
Contact Person Name
Marta Sobas
Contact Person Email
marta.sobas@cm.umk.pl
Site Name
Pratia S.A.
Department Name
Pratia MCM Krakow
Principal Investigator Name
Wojciech Jurczak
Principal Investigator Email
wojciech.jurczak@pratia.com
Contact Person Name
Wojciech Jurczak
Contact Person Email
wojciech.jurczak@pratia.com
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Klinika Hematoonkologii i Transplantacji Szpiku
Principal Investigator Name
Marek Hus
Principal Investigator Email
markhus@o2.pl
Contact Person Name
Marek Hus
Contact Person Email
markhus@o2.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Układu Chłonnego
Principal Investigator Name
Jan Walewski
Principal Investigator Email
jan.walewski@pib-nio.pl
Contact Person Name
Jan Walewski
Contact Person Email
jan.walewski@pib-nio.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Jan Zaucha
Principal Investigator Email
jzaucha@gumed.edu.pl
Contact Person Name
Jan Zaucha
Contact Person Email
jzaucha@gumed.edu.pl
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Principal Investigator Name
Sebastian Grosicki
Principal Investigator Email
sgrosicki@wp.pl
Contact Person Name
Sebastian Grosicki
Contact Person Email
sgrosicki@wp.pl
Site Name
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Department Name
Oddział Onkologii Klinicznej
Principal Investigator Name
Piotr Centkowski
Principal Investigator Email
pcentek@wp.pl
Contact Person Name
Piotr Centkowski
Contact Person Email
pcentek@wp.pl
Site Name
Aidport Sp. z o.o.
Principal Investigator Name
Michal Kwiatek
Principal Investigator Email
michal.kwiatek@aidport.pl
Contact Person Name
Michal Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Torun
Principal Investigator Name
Dominik Chraniuk
Principal Investigator Email
d.chraniuk@naszlekarz.pl
Contact Person Name
Dominik Chraniuk
Contact Person Email
d.chraniuk@naszlekarz.pl
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
Oddział Hematologiczny
Principal Investigator Name
Adam Walter-Croneck
Principal Investigator Email
awalter@cozl.pl
Contact Person Name
Adam Walter-Croneck
Contact Person Email
awalter@cozl.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
Principal Investigator Name
Tomasz Wrobel
Principal Investigator Email
tomasz_wrobel@wp.pl
Contact Person Name
Tomasz Wrobel
Contact Person Email
tomasz_wrobel@wp.pl

Romania

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
643
Number Of Sites
4
Number Of Participants
7

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Sectia Hematologie
Principal Investigator Name
Mihnea Tudor Zdrenghea
Principal Investigator Email
mzdrenghea@umfcluj.ro
Contact Person Name
Mihnea Tudor Zdrenghea
Contact Person Email
mzdrenghea@umfcluj.ro
Site Name
Institutul Clinic Fundeni
Department Name
Sectia Clinica Hematologie III
Principal Investigator Name
Ana-Maria Moldovianu
Principal Investigator Email
ana_maria_msg@yahoo.com
Contact Person Name
Ana-Maria Moldovianu
Contact Person Email
ana_maria_msg@yahoo.com
Site Name
Spitalul Clinic Municipal Filantropia Craiova
Department Name
Sectia Hematologie
Principal Investigator Name
Luminita Ocroteala
Principal Investigator Email
diaconu_luminita@yahoo.com
Contact Person Name
Luminita Ocroteala
Contact Person Email
diaconu_luminita@yahoo.com
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Sectia Hematologie
Principal Investigator Name
Catalin Danaila
Principal Investigator Email
c_danaila@yahoo.com
Contact Person Name
Catalin Danaila
Contact Person Email
c_danaila@yahoo.com

Czechia

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
05-02-2026
Processing Time Days
639
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
The 4th Department of Internal Medicine – Hematology
Principal Investigator Name
Martin Šimkovič
Principal Investigator Email
martin.simkovic@fnhk.cz
Contact Person Name
Martin Šimkovič
Contact Person Email
martin.simkovic@fnhk.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Internal hematology and oncology clinic
Principal Investigator Name
Jiří Mayer
Principal Investigator Email
mayer.jiri@fnbrno.cz
Contact Person Name
Jiří Mayer
Contact Person Email
mayer.jiri@fnbrno.cz

Portugal

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
640
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Oncohematology
Principal Investigator Name
Dulcineia Pereira
Principal Investigator Email
dulcineia@ipoporto.min-saude.pt
Contact Person Name
Dulcineia Pereira
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Serviço de Hematologia e Transplantação de Medula
Principal Investigator Name
Lídia Ribeiro
Principal Investigator Email
lidia.ribeiro@chln.min-saude.pt
Contact Person Name
Lídia Ribeiro

Italy

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
678
Number Of Sites
12
Number Of Participants
23

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Ematologia
Principal Investigator Name
Michele Merli
Principal Investigator Email
michele.merli@policlinico.mi.it
Contact Person Name
Michele Merli
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Ematologia
Principal Investigator Name
Marina Motta
Principal Investigator Email
marina.motta@asst-spedalicivili.it
Contact Person Name
Marina Motta
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Department Name
Ematologia
Principal Investigator Name
Federico Lussana
Principal Investigator Email
arambaldi@asst-pg23.it
Contact Person Name
Federico Lussana
Contact Person Email
arambaldi@asst-pg23.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Ematologia
Principal Investigator Name
Paolo Sportoletti
Principal Investigator Email
paolo.sportoletti@unipg.it
Contact Person Name
Paolo Sportoletti
Contact Person Email
paolo.sportoletti@unipg.it
Site Name
IRCCS Centro Di Riferimento Oncologico Della Basilicata
Department Name
Ematologia
Principal Investigator Name
Giuseppe Pietrantuono
Principal Investigator Email
giuseppe.pietrantuono@crob.it
Contact Person Name
Giuseppe Pietrantuono
Contact Person Email
giuseppe.pietrantuono@crob.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Ematologia
Principal Investigator Name
Anna MAria Frustaci
Principal Investigator Email
AnnaMaria.Frustaci@OspedaleNiguarda.it
Contact Person Name
Anna MAria Frustaci
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Ematologia
Principal Investigator Name
Monica Tani
Principal Investigator Email
monica.tani@auslromagna.it
Contact Person Name
Monica Tani
Contact Person Email
monica.tani@auslromagna.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Ematologia
Principal Investigator Name
Carlo Gambacorti-Passerini
Principal Investigator Email
carlo.gambacorti@unimib.it
Contact Person Name
Carlo Gambacorti-Passerini
Contact Person Email
carlo.gambacorti@unimib.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Onco-Ematologia
Principal Investigator Name
Gerardo Musuraca
Principal Investigator Email
gerardo.musuraca@irst.emr.it
Contact Person Name
Gerardo Musuraca
Contact Person Email
gerardo.musuraca@irst.emr.it
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
Oncologia medica
Principal Investigator Name
Gaetano Vaudo
Principal Investigator Email
vaudogaetano@gmail.com
Contact Person Name
Gaetano Vaudo
Contact Person Email
vaudogaetano@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Ematologia
Principal Investigator Name
Gianluca Gaidano
Principal Investigator Email
gianluca.gaidano@med.uniupo.it
Contact Person Name
Gianluca Gaidano
Contact Person Email
gianluca.gaidano@med.uniupo.it
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
Ematologia
Principal Investigator Name
Francesco Zaja
Principal Investigator Email
francesco.zaja@asugi.sanita.fvg.it
Contact Person Name
Francesco Zaja

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
IVRS and multiple clinical trial support functions (codes and duties provided in CTIS entry; IVRS explicitly listed)
Name
Eresearchtechnology Inc. (Clario)
Responsibilities
eCoA

Third parties

  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"labs kit creation, Clinical haematology","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"long-term storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Molecular Pathology Laboratory Network Inc.","duties_or_roles":"Deletion 17p, IGHV, Complex karyotype Bone, Marrow Aspirate","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCoA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"Patient travel assistant","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Clinical Logistics Inc.","duties_or_roles":"lab kit creation","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"Pharmacokinetics testing and storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"IVRS (and additional clinical trial support functions as listed in sponsor duties)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"Correlative studies & storage (bone marrow biopsy and aspirate, optional saliva DNA, MRD, cfDNA, PBM)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eli Lilly & Co.","duties_or_roles":"Susar reporting","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
PIRTOBRUTINIB
Active Substance
PIRTOBRUTINIB
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Not authorised
Maximum Dose
200 mg (max daily dose amount recorded 200 mg)
Investigational Product Name
RITUXIMAB
Active Substance
RITUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Not authorised for this sponsor product (used as comparator/relabelling for trial use)
Maximum Dose
500 mg/m2 (max daily dose amount recorded 500 mg/m2)
Investigational Product Name
BENDAMUSTINE
Active Substance
BENDAMUSTINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Not authorised for this sponsor product (relabelling/repackaging for clinical trial use)
Maximum Dose
90 mg/m2 (max daily dose amount recorded 90 mg/m2)
Combination Treatment
Yes

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