Phase
Condition
Leukemia
Lymphocytic Leukemia, Chronic
Leukemia (Pediatric)
Treatment
Epcoritamab
Lenalidomide
Pirtobrutinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
Evidence of CD20 positivity in a sample representative of the disease at Screening.
Acceptable hematology parameters and organ function based on baseline bloodwork.
Life expectancy >3 months on standard of care (SOC) for CLL, >3 months for RS.
For R/R CLL arms - Must have active CLL/SLL disease requiring treatment per iwCLL 2018 criteria.
For R/R CLL monotherapy arms - Received at least 2 prior lines of systemic anti-neoplastic therapy including a Bruton's tyrosine kinase (BTK) inhibitor or at least 1 prior line of systemic antineoplastic therapy, including treatment with (or intolerance of) a covalent BTK inhibitor (cBTKi) and a B-cell lymphoma 2 (BCL-2) inhibitor.
For all RS arms - Have tumor biopsy-proven CD20+ Diffuse large B-cell Lymphoma (DLBCL) and a clinical history of CLL/SLL.
For all RS arms - Must have measurable disease by fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT) or magnetic resonance imaging (MRI) scan.
For all RS arms - Must provide mandatory formalin-fixed, paraffin-embedded (FFPE) tumor biopsy sample.
For RS - monotherapy arm: Deemed as ineligible for chemoimmunotherapy at investigator's discretion or participant who refuses to receive intensive chemotherapy
For RS - lenalidomide combination therapy arm
Deemed as ineligible for chemoimmunotherapy at the investigator's discretion, or participant who refuses to receive intensive chemotherapy.
Eligible for treatment with lenalidomide.
Must be willing to use contraception and adhere to the Lenalidomide Pregnancy Risk Minimization Plan
A woman must agree not to breastfeed a child during treatment and for at least 28 days after discontinuation from study.
- For RS - R-CHOP combination Therapy Arm -
Eligible for treatment with R-CHOP.
Females of childbearing potential must use highly effective contraceptive measures while taking R-CHOP and for 12 months after stopping treatment.
A woman must agree not to breastfeed a child during treatment or until 12 months after last treatment.
- For R/R CLL - venetoclax combination Therapy arm - after receiving at least 1 prior line of systemic antineoplastic therapy.
Presence of measurable disease.
Must take prophylaxis for tumor lysis syndrome (TLS).
- For R/R CLL pirtobrutinib combination Therapy arm:
Must have active CLL/SLL disease requiring treatment per iwCLL 2018 criteria.
Presence of measurable disease.
Previous treatment with at least one and a maximum 3 prior lines of therapy including a cBTKi.
Diagnosis of CLL/SLL that met published iwCLL criteria.
- Participants with TN HR CLL - Pirtobrutinib Combination Therapy Expansion:
Diagnosis of CLL/SLL that met published iwCLL criteria 2018.
Must have active CLL/SLL disease that needs treatment per iwCLL
Must take prophylaxis for TLS based on their TLS risk evaluation upon initiation of trial drug.
Must have one or more high-risk features.
Presence of measurable disease.
Key Exclusion Criteria
Received prior treatment with a CD3×CD20 bispecific antibody.
Received any prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation.
Received chimeric antigen receptor (CAR) T-cell therapy within 100 days or an investigational drug within 4 weeks, prior to first dose of trial drug.
Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.
Received vaccination with live vaccines within 28 days.
Clinically significant cardiac disease.
Known current malignancy other than inclusion diagnosis.
Has had major surgery within 4 weeks.
Known history of human immunodeficiency virus (HIV).
For R/R CLL arms - Any history of RS or evidence indicating a potential Richter's transformation.
For R/R CLL - Venetoclax Combination Therapy arm: received venetoclax within 24 months prior to beginning venetoclax ramp-up for this trial or has progressed on venetoclax treatment.
For all RS arms - Diagnosis of Richter's syndrome not of the DLBCL subtype such as Hodgkin's lymphoma, prolymphocytic leukemia.
RS - Lenalidomide Combination Therapy and RS Monotherapy Arms - received more than 2 prior lines of therapy for RS.
R/R CLL - Pirtobrutinib Combination Therapy Arm - Prior exposure to a non-covalent (reversible) BTK inhibitor or a BTK degrader.
Pirtobrutinib Combination Therapy Expansion Arms:
History of bleeding disorders or participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
Require continuous treatment with or have received strong cytochrome P450 (CYP) 3A inhibitors or strong/moderate CYP3A inducers within 4 to 5 half-lives or 14 days prior to the first dose of pirtobrutinib.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
St George Hospital
Kogarah, New South Wales 2217
AustraliaSite Not Available
St. George Hospital
Kogarah, New South Wales
AustraliaActive - Recruiting
Flinders Medical Centre
Bedford Park, South Australia 5042
AustraliaActive - Recruiting
Barwon Health
Geelong, Victoria
AustraliaActive - Recruiting
University Hospital of Geelong
Geelong, Victoria 3220
AustraliaActive - Recruiting
Alfred Health
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
AZ Sint-Jan
Bruges, 8000
BelgiumActive - Recruiting
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumActive - Recruiting
UZ Leuven
Leuven, 3000
BelgiumActive - Recruiting
Vseobecna Fakultni Nemocnice
Praha, Nové Město 128 08
CzechiaActive - Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, Nový Hradec Králové 500 05
CzechiaActive - Recruiting
Fakultni Nemocnice Ostrava
Ostrava, Poruba
CzechiaActive - Recruiting
Fakultni nemocnice Brno
Brno, 625 00
CzechiaActive - Recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
CzechiaActive - Recruiting
Rigshospitalet
København, Hovedstaden 2100
DenmarkActive - Recruiting
Aalborg University Hospital
Aalborg, 9100
DenmarkActive - Recruiting
Odense University Hospital
Odense, 5000
DenmarkActive - Recruiting
Roskilde Sygehus
Roskilde, 4000
DenmarkActive - Recruiting
Vejle Sygehus
Vejle, 7100
DenmarkActive - Recruiting
Århus University Hospital
Århus, 8000
DenmarkActive - Recruiting
CHU de Montpellier Hôpital Saint Eloi
Montpellier, Cedex 5 34090
FranceActive - Recruiting
CHU Hôpital Haut-Lévêque Bordeaux
Pessac, Gironde 33404
FranceActive - Recruiting
CHU Hôpital de Brabois Nancy
Vandœuvre-lès-Nancy, Meurthe et Moselle 54500
FranceActive - Recruiting
Hopital Saint Eloi
Montpellier, Occitania 34090
FranceActive - Recruiting
Hôpital Privé du Confluent
Nantes, Pays de la Loire 44000
FranceActive - Recruiting
CHU Clermont Ferrand
Clermont Ferrand cedex, Puy de Dome 63000
FranceActive - Recruiting
Groupe Hospitalier Pitie-Salpetriere
Paris, 75013
FranceActive - Recruiting
Hôpital Saint-Louis
Paris, 75010
FranceActive - Recruiting
Hôpital Universitaire Pitié-Salpêtrière
Paris, 75013
FranceActive - Recruiting
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604
FranceActive - Recruiting
CHU de Nancy - Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, 54500
FranceActive - Recruiting
Universitaetsklinikum Ulm
Ulm, Baden Wuerttemberg 89070
GermanyActive - Recruiting
Universitaetsklinikum Schleswig-Holstein- Karl-Lennart-Krebscentrum
Kiel, 24105
GermanyActive - Recruiting
Universitaetsklinikum Koeln
Koeln, 50937
GermanyActive - Recruiting
University of Cologne
Köln,
GermanySite Not Available
Bnai Zion Medical Center
Haifa,
IsraelActive - Recruiting
Hadassah University Hospital - Ein Kerem
Jerusalem,
IsraelActive - Recruiting
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492
IsraelActive - Recruiting
Chaim Sheba Medical Center
Ramat Gan,
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv-Yafo,
IsraelActive - Recruiting
Istituto di Candiolo
Torino, Candiolo 10060
ItalyActive - Recruiting
AOU Arcispedale Sant'Anna
Ferrara, Cona 44124
ItalyActive - Recruiting
IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
Meldola, Forli - Cesena 47014
ItalyActive - Recruiting
IRCCS Policlinico Universitario Agostino Gemelli
Roma, Lazio 00136
ItalyActive - Recruiting
AOU Policlinico Sant'Orsola Malpighi IRCCS
Bologna, 00161
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia,
ItalyActive - Recruiting
Ospedale San Raffaele
Milano, 20132
ItalyActive - Recruiting
Ospedale Maggiore di Novara
Novara, 28100
ItalyActive - Recruiting
AOU Policlinico Umberto I
Roma, 00161
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
ItalyActive - Recruiting
AOU Città della Salute e della Scienza di Torino
Torino, 10126
ItalyActive - Recruiting
Maastricht University Medical Center
Maastricht, Limburg 6229 HX
NetherlandsActive - Recruiting
Albert Schweitzer Ziekenhuis, Dordwijk
Dordrecht, South Holland 3318 AT
NetherlandsActive - Recruiting
Amsterdam UMC
Amsterdam, 1105 AZ
NetherlandsActive - Recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
NetherlandsActive - Recruiting
UMC Utrecht
Utrecht, 3584 CX
NetherlandsActive - Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
NetherlandsActive - Recruiting
Pratia Medical Center Katowice (Centrum Medyczne Pratia Katowice)
Katowice,
PolandActive - Recruiting
Pratia Malopolskie Medical Center Krakow (Pratia Małopolskie Centrum Medyczne Krakow)
Kraków,
PolandActive - Recruiting
Aidport sp z o.o.
Skorzewo,
PolandActive - Recruiting
ICO Badalona - Hospital Universitario Germans Trias Pujol
Badalona, Barcelona
SpainActive - Recruiting
AOC Arcispedale Saint'Anna
Coaña, Ferarra
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia
Valencia, València 46010
SpainActive - Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona,
SpainActive - Recruiting
Hospital Universitario Fundacion Jiménez Díaz
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
SpainActive - Recruiting
Hospital Universitario Virgen Macarena
Sevilla,
SpainActive - Recruiting
Royal Cornwall Hospital
Truro, Cornwall TR1 3LJ
United KingdomSite Not Available
Nottingham University Hospitals City Campus
Nottingham, Nottinghamshire
United KingdomSite Not Available
St. James s University Hospital
Leeds, West Yorkshire
United KingdomActive - Recruiting
Barts Hospital
London, EC1A 7BE
United KingdomActive - Recruiting
O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesActive - Recruiting
University of Alabama
Tuscaloosa, Alabama 35487
United StatesSite Not Available
University of California Davis Medical Center Sacramento
California, California 95817
United StatesActive - Recruiting
University of California Davis Medical Center Sacramento
California City, California 95817
United StatesSite Not Available
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
City of Hope National Medical Center
Duarte, California 91010
United StatesActive - Recruiting
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
David Geffen School of Medicine
Los Angeles, California 90095
United StatesActive - Recruiting
Stanford Cancer Center
Palo Alto, California 94305
United StatesActive - Recruiting
Stanford University School of Medicine
Stanford, California 94305
United StatesSite Not Available
Memorial Healthcare System
Hollywood, Florida 33021
United StatesSite Not Available
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
United StatesActive - Recruiting
Memorial Healthcare System
Pembroke Pines, Florida 33024
United StatesActive - Recruiting
National Institutes of Health
Bethesda, Maryland 20892
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48190
United StatesActive - Recruiting
Henry Ford Medical Group
Detroit, Michigan 48202
United StatesActive - Recruiting
Hackensack Meridian Hospital
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Duke University Medical Center
Durham, New York 27710
United StatesActive - Recruiting
Northwell Health Cancer Institute
Lake Success, New York 11043
United StatesActive - Recruiting
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United StatesActive - Recruiting
Columbia University Hervert Irving Comprehensive Cancer Center
New York, New York 10032
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
University of Cincinnati
Cincinnati, Ohio 45221
United StatesSite Not Available
James Cancer Hospital
Columbus, Ohio 43210
United StatesActive - Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesActive - Recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
University of Pennsylvania School of medicine
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
The University of Texas Southwestern Medical Centre
Dallas, Texas 75390
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United StatesActive - Recruiting
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