search
Back to results

Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)

Primary Purpose

Mantle-Cell Lymphoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ibrutinib
Venetoclax
Placebo Oral tablet to match Venetoclax
Sponsored by
Pharmacyclics LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle-Cell Lymphoma focused on measuring PCYC, MCL, Non-Hodgkin's Lymphoma, NHL, ibrutinib, venetoclax, Pharmacyclics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Relapsed/Refractory Arm

Inclusion Criteria:

  • Pathologically confirmed MCL (in tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR).
  • At least 1 measurable site of disease on cross-sectional imaging (CT/PET).
  • At least 1, but no more than 5, prior treatment regimens for MCL.
  • Failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
  • Subjects must have adequate fresh or paraffin embedded tissue.
  • Adequate hematologic, hepatic and renal function.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <= 2.

Exclusion Criteria:

  • History or current evidence of central nervous system lymphoma.
  • Concurrent enrollment in another therapeutic investigational study or prior therapy with ibrutinib or other BTK inhibitors.
  • Prior treatment with venetoclax or other BCL2 inhibitors.
  • Anticancer therapy including chemotherapy, radiotherapy, small molecule and investigational agents 21 days prior to receiving the first dose of study drug.
  • Treatment with any of the following within 7 days prior to the first dose of study drug: moderate or strong cytochrome P450 3A (CYP3A) inhibitors or strong CYP3A inducers.

Treatment Naïve Arm

Inclusion Criteria:

  • Pathologically confirmed treatment-naive MCL (tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14), as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR).
  • Men and women ≥18 years of age with a TP53 mutation.
  • At least 1 measurable site of disease.
  • Must have adequate fresh or paraffin-embedded tissue.
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
  • Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

  • Blastoid variant of MCL
  • History or current evidence of CNS lymphoma.
  • Concurrent enrollment in another therapeutic investigational study or prior therapy including ibrutinib or other BTK inhibitors.
  • Prior treatment with venetoclax or other BCL2 inhibitors.
  • Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.
  • Clinically significant infection requiring IV systemic treatment that was completed <=14 days before the first dose of study drug.
  • Any uncontrolled active systemic infection.
  • Known bleeding disorders (eg, von Willebrand's disease or hemophilia).
  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  • History of HIV or active HCV or HBV.
  • Major surgery within 4 weeks of the first dose of study drug.
  • Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the participant's safety or put the study outcomes at undue risk.
  • Currently active, clinically significant cardiovascular disease; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
  • Unable to swallow capsules or tablets, or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
  • Treatment with any of the following within 7 days prior to the first dose of study drug: Moderate or strong cytochrome P450 3A (CYP3A) inhibitors or moderate or strong CYP3A inducers.
  • Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects with known risk factors (as defined by high tumor burden and/or diminished renal function, as detailed in "Study Design" section above) for TLS.
  • Chronic liver disease with hepatic impairment Child-Pugh class B or C.
  • Unwilling or unable to participate in all required study evaluations and procedures.
  • Known hypersensitivity to the active ingredient or other components of one or more study drugs.

Sites / Locations

  • The University of Arizona Cancer Centre-North Campus
  • City of Hope
  • UCLA Department of Medicine-Hematology/Oncology
  • Orlando Health Inc.
  • The University of Kansas Cancer Center and Medical Pavilion
  • Norton Cancer Institute
  • Barbara Ann Karmanos Cancer institute
  • Memorial Sloan Kettering Cancer Center
  • Stony Brook University
  • Levine Cancer Institute
  • Tennessee Oncology
  • University of Tennessee medical Center
  • University of Texas MD Anderson Cancer Center
  • Swedish Cancer Institute
  • The Canberra Hospital
  • Border Medical Oncology Research Unit
  • Icon Cancer Care
  • Austin Health
  • Peter MacCallum Cancer
  • St.Vincent's Hospital
  • Sir Charles Gairdner Hospital
  • ZiekenhuisNetwerk Antwerpen (ZNA) Stuivenberg
  • AZ Sint-Jan Brugge-Oostende AV
  • Institut Jules Bordet
  • CHU UCL Namur asbl- Mont Godinne
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • BC Cancer-Vancouver Centre
  • Queen Elizabeth II Health Science Centre
  • The Ottawa Hospital
  • Jewish General Hospital
  • FN Brno, Interni hematologicka a onkologicka klinika
  • Fakultni Nemocnice (FN) Hradec Kravlove, a.s. IV. Interni hematologicka klinika
  • FN Olomouc
  • FN Ostrava
  • Fakultni nemocnice Kralovske Vinohrady
  • Vseobecna fakultni nemocnice v Praze, l. interni klinika-klinika hematologie
  • CHU CAEN-Hôpital de la Côte de Nacre
  • Institut Bergonié
  • CHU Clermont Ferrand - Hôpital d'Estaing
  • Institut Paoli Calmettes, Service Hematologie
  • Centre Antoine Lacassagne
  • Hôpital Saint-Louis
  • Centre Hospitalier Lyon Sud
  • CHU de Tours
  • Kliniken Ostalb Stauferklinikum Schwab. Gmund
  • Universitaetsklinikum Ulm
  • Klinikum der Universitaet Muenchen Campus Grosshadern
  • Universitatsklinikum Koln
  • Universitaetsmedizin der Johannes Gutenberg, Langenbeckstrasse 1
  • Gemeinschaftpraxis Haematologie und Onkologie
  • Vivantes Klinikum Am Urban
  • Charite- Universitatsmedizin Berlin, Campus Benjamin Franklin
  • Universitatsklinikum Essen, Klinik fur Hamatologie
  • Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin I
  • University Hospital of Alexandroupolis
  • 251 Air Force General Hospital
  • General Hospital of Athens Laiko
  • General Hospital of Athens "Alexandra"
  • University General Hospital of Ioannina
  • University General Hospital of Larissa
  • University Hospital of Patras
  • Orszagos Onkologiai Intezet
  • Semmelweis Egyetem
  • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika
  • Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat-Hematologia
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Markusovszky Egyetemi Oktatokorhaz, Haematologiai es Haemoszatazeologiai Osztaly
  • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
  • Azienda Ospedaliera Universitaria di Bologna Policlinico Saint Orsola Malpighi
  • ASST degli Spedali Civili di Brescia
  • Azienda Ospedaliera S. Croce e Carle Cuneo
  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
  • IRCCS Ospedale S. Raffaele di Milano
  • Asst Grande Ospedale Metropolitano Niguarda
  • Fondazione IRCCS Policlinico San Matteo
  • Azienda Ospedaliero Universitaria Molinette San Giovanni Battista di Torino
  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
  • Gachon University Gil Medical Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Universitair Medisch Centrum Groningen
  • Spaarne Gasthuis
  • Leiden University Medical Center
  • Erasmus MC
  • Franciscus Vlietland
  • Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszcz
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Oddzial Hematologiczny
  • Malopolskie Centrum Medyczne s c
  • Instytut Hematologii i Transfuzjologii
  • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu, PZOZ
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi
  • Hospital Universitario de Cabuenes
  • Hospital Universitari Germans Trias I Pujol
  • ICO l'Hospitalet- Hospital Duran i Reynals
  • Clinica Universidad de Navarra
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario Ramon y Cajal
  • Fundacion Jimenez Diaz
  • Ondokuz Mayiz universitesi Tip Fakultesi
  • Gazi Universitesi Tip Fakultesi, Besevler
  • Dokuz Eylul Universitesi Tip Fakultesi
  • Namik Kemal Universitesi Saglik Uyg. ve.Ars. Hastanesi
  • Communal Nonprofit enterprise Cherkasy Regional Oncology Dispensary ofCherkasy Oblast Council,Regional Treatment and Diagnostic Hematological Center
  • Communal Non-profit Enterprise Regional Center of Oncology, Department of Hematology
  • National Inst. of Cancer, Scientific and Research Dept of Chemotherapy of Hemoblastosis and Adjuvant Treatment Methods, Dept of Oncohematology with Sector of Adjuvant treatment methods
  • SI national Scientific Center of Radiation Medicine of NAMS of Ukraine, Dep. of Radiation Oncohematology and Stem Cell Transplantation Unit
  • Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Hematology
  • Communal Institution O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council Dept of Hematology with beds of Intensive Therapy
  • Barts Health NHS Trust
  • The Christie NHS Foundation Trust
  • Nottingham University Hospitals NHS Trust
  • The Churchill Hospital
  • The Royal Marsden NHS Foundation Trust
  • St James University Hospital
  • University College London Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Safety Run-in Period

Phase 3: Ibrutinb + Venetoclax

Phase 3: Ibrutinib + Placebo

Treatment-naive

Arm Description

Subjects are enrolled into the open-label Safety Run-in Period to evaluate the occurrence of tumor lysis syndrome (TLS) and DLTs with the concurrent administration of ibrutinib and venetoclax. Safety run-in phase for the study is closed to further enrollment as of 07-Nov-2018.

Subjects will be randomized to receive ibrutinib and venetoclax/placebo until clinical disease progression or unacceptable toxicity

Subjects will be randomized to receive ibrutinib and venetoclax/placebo until clinical disease progression or unacceptable toxicity

This open-label arm is designed to explore the efficacy and safety of the combination of ibrutinib and venetoclax in subjects with treatment-naive MCL. Approximately 75 subjects (of which ~25 subjects with TP53 mutation) will be enrolled and treated with ibrutinib and venetoclax.

Outcomes

Primary Outcome Measures

Occurrence of Tumor Lysis Syndrome (TLS) (Safety Run-in Period)
To evaluate the occurrence of tumor lysis syndrome (TLS) with the concurrent administration of ibrutinib and venetoclax.
Occurrence of Dose Limiting Toxicities (DLT) (Safety Run-in Period)
To evaluate the occurrence of DLTs with the concurrent administration of ibrutinib and venetoclax.
Number of Participants With Adverse Events (AEs) (Safety Run-in Period)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Overall response rate (ORR) (Safety Run-in Period)
ORR is defined as CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma.
Duration of Response (DOR) (Safety Run-in Period)
DOR is defined as participants who achieve an overall response as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
Progression-free Survival (PFS) (Safety Run-in Period)
To evaluate PFS of ibrutinib and venetoclax compared to ibrutinib and placebo.
Overall Survival (OS) (Safety Run-in Period)
OS is defined as the time from the date of the first dose of study treatment to death from any cause.
Progression-free Survival (PFS) (Randomization Period)
To evaluate PFS of ibrutinib and venetoclax compared to ibrutinib and placebo.
Complete Response (CR) (Treatment-Naive Arm)
To evaluate the complete response (CR) rate with the combination of ibrutinib and venetoclax in subjects with treatment-naive MCL

Secondary Outcome Measures

Complete Response (CR) (Randomization Period)
Complete response rate (CR) based on the best overall response per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma.
Overall response rate (ORR) (Randomization Period and Treatment-Naive Arm)
ORR is defined as CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma.
MRD-negative remission rate in participants who achieve CR per investigator assessment (Randomization Period and Treatment-Naive Arm)
MRD-negative remission is defined as undetectable MRD at documented CR in subjects who were MRD positive at screening as assessed by flow cytometry in bone marrow and/or peripheral blood, with requirement of confirmation of MRD negativity in the subsequent peripheral blood 12 weeks later.
Overall Survival (OS) (Randomization Period and Treatment-Naive Arm)
OS is defined as the time from the date of the first dose of study treatment to death from any cause.
Duration of Response (DOR) (Randomization Period and Treatment-Naive Arm)
DOR is defined as participants who achieve an overall response as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
Time to Next Treatment (TTNT) (Randomization Period and Treatment-Naive Arm)
TTNT is defined as the duration from the date of randomization to the start date of any anti-lymphoma treatment subsequent to study treatment.
Percentage of participants experiencing Adverse Events (Randomization Period)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Occurrence of Tumor Lysis Syndrome (TLS) (Randomization Period)
To evaluate the occurrence of tumor lysis syndrome (TLS) with the concurrent administration of ibrutinib and venetoclax.
Cmax if Ibrutinib (Randomization Period)
Cmax if Ibrutinib.
Tmax if Ibrutinib (Randomization Period)
Tmax if Ibrutinib.
AUClast if Ibrutinib (Randomization Period)
AUClast if Ibrutinib.
Half-Life (T1/2) if Ibrutinib (Randomization Period)
Half-Life (T1/2) if Ibrutinib.
Cmax of Venetoclax (Randomization Period)
Cmax of Venetoclax.
Tmax of Venetoclax (Randomization Period)
Tmax of Venetoclax.
AUC of Venetoclax (Randomization Period)
AUC of Venetoclax.
Time to worsening in FACT-Lym subscale of the health-related quality of life (Randomization Period) questionnaire (FACT-Lym)
Time to worsening in FACT-Lym subscale of the health-related quality of life questionnaire (FACT-Lym) will be compared between treatment arms.
Duration of CR (Treatment-Naive Arm Period)
Duration of CR, defined for subjects who achieve CR as the time from the first occurrence of CR to disease progression or death, whichever occurs first.
Progression-free Survival (PFS) (Treatment-Naive Arm Period)
To evaluate PFS of ibrutinib and venetoclax compared to ibrutinib and placebo.

Full Information

First Posted
April 4, 2017
Last Updated
September 26, 2023
Sponsor
Pharmacyclics LLC.
Collaborators
Janssen Research & Development, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03112174
Brief Title
Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)
Official Title
Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
November 15, 2024 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics LLC.
Collaborators
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle-Cell Lymphoma
Keywords
PCYC, MCL, Non-Hodgkin's Lymphoma, NHL, ibrutinib, venetoclax, Pharmacyclics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety Run-in Period
Arm Type
Experimental
Arm Description
Subjects are enrolled into the open-label Safety Run-in Period to evaluate the occurrence of tumor lysis syndrome (TLS) and DLTs with the concurrent administration of ibrutinib and venetoclax. Safety run-in phase for the study is closed to further enrollment as of 07-Nov-2018.
Arm Title
Phase 3: Ibrutinb + Venetoclax
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive ibrutinib and venetoclax/placebo until clinical disease progression or unacceptable toxicity
Arm Title
Phase 3: Ibrutinib + Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be randomized to receive ibrutinib and venetoclax/placebo until clinical disease progression or unacceptable toxicity
Arm Title
Treatment-naive
Arm Type
Experimental
Arm Description
This open-label arm is designed to explore the efficacy and safety of the combination of ibrutinib and venetoclax in subjects with treatment-naive MCL. Approximately 75 subjects (of which ~25 subjects with TP53 mutation) will be enrolled and treated with ibrutinib and venetoclax.
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Intervention Description
Administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Intervention Description
Administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo Oral tablet to match Venetoclax
Intervention Description
Administered orally once daily
Primary Outcome Measure Information:
Title
Occurrence of Tumor Lysis Syndrome (TLS) (Safety Run-in Period)
Description
To evaluate the occurrence of tumor lysis syndrome (TLS) with the concurrent administration of ibrutinib and venetoclax.
Time Frame
Approximately 3 months after last subject enrolled into safety run-in portion
Title
Occurrence of Dose Limiting Toxicities (DLT) (Safety Run-in Period)
Description
To evaluate the occurrence of DLTs with the concurrent administration of ibrutinib and venetoclax.
Time Frame
Approximately 3 months after last subject enrolled into safety run-in portion
Title
Number of Participants With Adverse Events (AEs) (Safety Run-in Period)
Description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time Frame
Up to approximately 5 years
Title
Overall response rate (ORR) (Safety Run-in Period)
Description
ORR is defined as CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma.
Time Frame
approximately 1 year after last subject has stopped treatment with study drug(s)
Title
Duration of Response (DOR) (Safety Run-in Period)
Description
DOR is defined as participants who achieve an overall response as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
Time Frame
Up to approximately 5 years
Title
Progression-free Survival (PFS) (Safety Run-in Period)
Description
To evaluate PFS of ibrutinib and venetoclax compared to ibrutinib and placebo.
Time Frame
approximately 1 year after last subject has stopped treatment with study drug(s)
Title
Overall Survival (OS) (Safety Run-in Period)
Description
OS is defined as the time from the date of the first dose of study treatment to death from any cause.
Time Frame
Up to approximately 5 years
Title
Progression-free Survival (PFS) (Randomization Period)
Description
To evaluate PFS of ibrutinib and venetoclax compared to ibrutinib and placebo.
Time Frame
approximately 1 year after last subject has stopped treatment with study drug(s)
Title
Complete Response (CR) (Treatment-Naive Arm)
Description
To evaluate the complete response (CR) rate with the combination of ibrutinib and venetoclax in subjects with treatment-naive MCL
Time Frame
approximately 1 year after last subject has stopped treatment with study drug(s)
Secondary Outcome Measure Information:
Title
Complete Response (CR) (Randomization Period)
Description
Complete response rate (CR) based on the best overall response per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma.
Time Frame
approximately 1 year after last subject has stopped treatment with study drug(s)
Title
Overall response rate (ORR) (Randomization Period and Treatment-Naive Arm)
Description
ORR is defined as CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma.
Time Frame
approximately 1 year after last subject has stopped treatment with study drug(s)
Title
MRD-negative remission rate in participants who achieve CR per investigator assessment (Randomization Period and Treatment-Naive Arm)
Description
MRD-negative remission is defined as undetectable MRD at documented CR in subjects who were MRD positive at screening as assessed by flow cytometry in bone marrow and/or peripheral blood, with requirement of confirmation of MRD negativity in the subsequent peripheral blood 12 weeks later.
Time Frame
approximately 1 year after last subject has stopped treatment with study drug(s)
Title
Overall Survival (OS) (Randomization Period and Treatment-Naive Arm)
Description
OS is defined as the time from the date of the first dose of study treatment to death from any cause.
Time Frame
Up to approximately 5 years
Title
Duration of Response (DOR) (Randomization Period and Treatment-Naive Arm)
Description
DOR is defined as participants who achieve an overall response as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
Time Frame
Up to approximately 5 years
Title
Time to Next Treatment (TTNT) (Randomization Period and Treatment-Naive Arm)
Description
TTNT is defined as the duration from the date of randomization to the start date of any anti-lymphoma treatment subsequent to study treatment.
Time Frame
Up to approximately 5 years
Title
Percentage of participants experiencing Adverse Events (Randomization Period)
Description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to approximately 5 years
Title
Occurrence of Tumor Lysis Syndrome (TLS) (Randomization Period)
Description
To evaluate the occurrence of tumor lysis syndrome (TLS) with the concurrent administration of ibrutinib and venetoclax.
Time Frame
Approximately 3 months after last subject enrolled into safety run-in portion
Title
Cmax if Ibrutinib (Randomization Period)
Description
Cmax if Ibrutinib.
Time Frame
Week 6
Title
Tmax if Ibrutinib (Randomization Period)
Description
Tmax if Ibrutinib.
Time Frame
Week 6
Title
AUClast if Ibrutinib (Randomization Period)
Description
AUClast if Ibrutinib.
Time Frame
Week 6
Title
Half-Life (T1/2) if Ibrutinib (Randomization Period)
Description
Half-Life (T1/2) if Ibrutinib.
Time Frame
Week 6
Title
Cmax of Venetoclax (Randomization Period)
Description
Cmax of Venetoclax.
Time Frame
Week 6
Title
Tmax of Venetoclax (Randomization Period)
Description
Tmax of Venetoclax.
Time Frame
Week 6
Title
AUC of Venetoclax (Randomization Period)
Description
AUC of Venetoclax.
Time Frame
Week 6
Title
Time to worsening in FACT-Lym subscale of the health-related quality of life (Randomization Period) questionnaire (FACT-Lym)
Description
Time to worsening in FACT-Lym subscale of the health-related quality of life questionnaire (FACT-Lym) will be compared between treatment arms.
Time Frame
Week 6
Title
Duration of CR (Treatment-Naive Arm Period)
Description
Duration of CR, defined for subjects who achieve CR as the time from the first occurrence of CR to disease progression or death, whichever occurs first.
Time Frame
Up to approximately 5 years
Title
Progression-free Survival (PFS) (Treatment-Naive Arm Period)
Description
To evaluate PFS of ibrutinib and venetoclax compared to ibrutinib and placebo.
Time Frame
approximately 1 year after last subject has stopped treatment with study drug(s)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Relapsed/Refractory Arm Inclusion Criteria: Pathologically confirmed MCL (in tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR). At least 1 measurable site of disease on cross-sectional imaging (CT/PET). At least 1, but no more than 5, prior treatment regimens for MCL. Failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen. Subjects must have adequate fresh or paraffin embedded tissue. Adequate hematologic, hepatic and renal function. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <= 2. Exclusion Criteria: History or current evidence of central nervous system lymphoma. Concurrent enrollment in another therapeutic investigational study or prior therapy with ibrutinib or other BTK inhibitors. Prior treatment with venetoclax or other BCL2 inhibitors. Anticancer therapy including chemotherapy, radiotherapy, small molecule and investigational agents 21 days prior to receiving the first dose of study drug. Treatment with any of the following within 7 days prior to the first dose of study drug: moderate or strong cytochrome P450 3A (CYP3A) inhibitors or strong CYP3A inducers. Treatment Naïve Arm Inclusion Criteria: Pathologically confirmed treatment-naive MCL (tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14), as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR). Men and women ≥18 years of age with a TP53 mutation. At least 1 measurable site of disease. Must have adequate fresh or paraffin-embedded tissue. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2. Adequate hematologic, hepatic, and renal function. Exclusion Criteria: Blastoid variant of MCL History or current evidence of CNS lymphoma. Concurrent enrollment in another therapeutic investigational study or prior therapy including ibrutinib or other BTK inhibitors. Prior treatment with venetoclax or other BCL2 inhibitors. Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug. Clinically significant infection requiring IV systemic treatment that was completed <=14 days before the first dose of study drug. Any uncontrolled active systemic infection. Known bleeding disorders (eg, von Willebrand's disease or hemophilia). History of stroke or intracranial hemorrhage within 6 months prior to enrollment. History of HIV or active HCV or HBV. Major surgery within 4 weeks of the first dose of study drug. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the participant's safety or put the study outcomes at undue risk. Currently active, clinically significant cardiovascular disease; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization. Unable to swallow capsules or tablets, or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction. Treatment with any of the following within 7 days prior to the first dose of study drug: Moderate or strong cytochrome P450 3A (CYP3A) inhibitors or moderate or strong CYP3A inducers. Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects with known risk factors (as defined by high tumor burden and/or diminished renal function, as detailed in "Study Design" section above) for TLS. Chronic liver disease with hepatic impairment Child-Pugh class B or C. Unwilling or unable to participate in all required study evaluations and procedures. Known hypersensitivity to the active ingredient or other components of one or more study drugs.
Facility Information:
Facility Name
The University of Arizona Cancer Centre-North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCLA Department of Medicine-Hematology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Orlando Health Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The University of Kansas Cancer Center and Medical Pavilion
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Barbara Ann Karmanos Cancer institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University
City
New York
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Tennessee Oncology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
University of Tennessee medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98194
Country
United States
Facility Name
The Canberra Hospital
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Border Medical Oncology Research Unit
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Icon Cancer Care
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Peter MacCallum Cancer
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
St.Vincent's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
ZiekenhuisNetwerk Antwerpen (ZNA) Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
CHU UCL Namur asbl- Mont Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1 Z2
Country
Canada
Facility Name
BC Cancer-Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Queen Elizabeth II Health Science Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
FN Brno, Interni hematologicka a onkologicka klinika
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni Nemocnice (FN) Hradec Kravlove, a.s. IV. Interni hematologicka klinika
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
FN Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
FN Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze, l. interni klinika-klinika hematologie
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
CHU CAEN-Hôpital de la Côte de Nacre
City
CAEN Cedex
State/Province
Calvados
ZIP/Postal Code
14033
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Clermont Ferrand - Hôpital d'Estaing
City
Clermont Ferrand cedex
ZIP/Postal Code
63003
Country
France
Facility Name
Institut Paoli Calmettes, Service Hematologie
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice Cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite cedex
ZIP/Postal Code
69495
Country
France
Facility Name
CHU de Tours
City
Tours Cedex 01
ZIP/Postal Code
37044
Country
France
Facility Name
Kliniken Ostalb Stauferklinikum Schwab. Gmund
City
Mutlangen
State/Province
Baden-Wuttemberg
ZIP/Postal Code
73557
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
State/Province
Baden-Wuttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen Campus Grosshadern
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitatsklinikum Koln
City
Kerpen
State/Province
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg, Langenbeckstrasse 1
City
Langen
State/Province
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Gemeinschaftpraxis Haematologie und Onkologie
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Vivantes Klinikum Am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Charite- Universitatsmedizin Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitatsklinikum Essen, Klinik fur Hamatologie
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin I
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
University Hospital of Alexandroupolis
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Facility Name
251 Air Force General Hospital
City
Athens
ZIP/Postal Code
11525
Country
Greece
Facility Name
General Hospital of Athens Laiko
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Athens "Alexandra"
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
University General Hospital of Ioannina
City
Ioánnina
ZIP/Postal Code
45500
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
University Hospital of Patras
City
Patra
ZIP/Postal Code
26504
Country
Greece
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat-Hematologia
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatokorhaz, Haematologiai es Haemoszatazeologiai Osztaly
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria
City
Alessandria
State/Province
Alessandria/Piemonte
ZIP/Postal Code
15121
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
City
Bergamo
State/Province
Bergamo/Lombardia
ZIP/Postal Code
21427
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Bologna Policlinico Saint Orsola Malpighi
City
Bologna
State/Province
Bologna/Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST degli Spedali Civili di Brescia
City
Brescia
State/Province
Brescia/Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera S. Croce e Carle Cuneo
City
Cuneo
State/Province
Cuneo/Piemonte
ZIP/Postal Code
12100
Country
Italy
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
City
Meldola
State/Province
Forli-Cesena/Emilia-Rom
ZIP/Postal Code
47014
Country
Italy
Facility Name
IRCCS Ospedale S. Raffaele di Milano
City
Milano
State/Province
Milano/Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Asst Grande Ospedale Metropolitano Niguarda
City
Milano
State/Province
Milano/Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
State/Province
Pavia/Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Molinette San Giovanni Battista di Torino
City
Torino
State/Province
Torino/Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
City
Udine
State/Province
Udine/Friuli-Venezia Giulia
ZIP/Postal Code
33010
Country
Italy
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Spaarne Gasthuis
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Franciscus Vlietland
City
Schiedam
ZIP/Postal Code
3118 JH
Country
Netherlands
Facility Name
Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszcz
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Oddzial Hematologiczny
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Malopolskie Centrum Medyczne s c
City
Kraków
ZIP/Postal Code
30-510Komisja Bioctyczn
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu, PZOZ
City
Wrocław
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Hospital Universitario de Cabuenes
City
Gijón
State/Province
Asturias
ZIP/Postal Code
33203
Country
Spain
Facility Name
Hospital Universitari Germans Trias I Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
ICO l'Hospitalet- Hospital Duran i Reynals
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Ondokuz Mayiz universitesi Tip Fakultesi
City
Kurupelit
State/Province
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Gazi Universitesi Tip Fakultesi, Besevler
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi
City
İzmir
Country
Turkey
Facility Name
Namik Kemal Universitesi Saglik Uyg. ve.Ars. Hastanesi
City
Tekirdağ
ZIP/Postal Code
59030
Country
Turkey
Facility Name
Communal Nonprofit enterprise Cherkasy Regional Oncology Dispensary ofCherkasy Oblast Council,Regional Treatment and Diagnostic Hematological Center
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Communal Non-profit Enterprise Regional Center of Oncology, Department of Hematology
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
National Inst. of Cancer, Scientific and Research Dept of Chemotherapy of Hemoblastosis and Adjuvant Treatment Methods, Dept of Oncohematology with Sector of Adjuvant treatment methods
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
SI national Scientific Center of Radiation Medicine of NAMS of Ukraine, Dep. of Radiation Oncohematology and Stem Cell Transplantation Unit
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Hematology
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
Communal Institution O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council Dept of Hematology with beds of Intensive Therapy
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Barts Health NHS Trust
City
London
State/Province
Greater London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
The Churchill Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34717692
Citation
Wang M, Ramchandren R, Chen R, Karlin L, Chong G, Jurczak W, Wu KL, Bishton M, Collins GP, Eliadis P, Peyrade F, Lee Y, Eckert K, Neuenburg JK, Tam CS. Concurrent ibrutinib plus venetoclax in relapsed/refractory mantle cell lymphoma: the safety run-in of the phase 3 SYMPATICO study. J Hematol Oncol. 2021 Oct 30;14(1):179. doi: 10.1186/s13045-021-01188-x.
Results Reference
derived

Learn more about this trial

Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)

We'll reach out to this number within 24 hrs