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A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma (VEGA)

Primary Purpose

Lymphoma, Mantle-Cell

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ibrutinib
Lenalidomide
Rituximab
Bortezomib
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Mantle-Cell

Eligibility Criteria

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

Inclusion Criteria:

  • At least 1 prior treatment regimen for mantle cell lymphoma (MCL) excluding inhibitor of Bruton's tyrosine kinase (BTKi)
  • Documented disease progression or relapse following the last anti-MCL treatment
  • At least 1 measurable site of disease on cross-sectional imaging that is greater than or equal to (>=) 2.0 centimeters (cm) in the longest diameter and measurable in 2 perpendicular dimensions per computed tomography (CT)
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1

Exclusion Criteria:

  • Prior therapy with ibrutinib or other BTK inhibitor
  • Prior treatment with both lenalidomide and bortezomib. Prior treatment with only 1 of these therapies is allowed
  • Major surgery within 4 weeks of randomization
  • Concurrent enrollment in another therapeutic investigational study
  • Known central nervous system lymphoma
  • History of stroke or intracranial hemorrhage within 6 months prior to randomization

Sites / Locations

  • Santa Casa de Misericordia de Belo Horizonte
  • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
  • Ynova Pesquisa Clinica
  • Liga Norte Riograndense Contra O Cancer
  • Complexo Hospitalar de Niterói
  • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
  • Oncoclínicas Rio de Janeiro S.A.
  • Instituto de Ensino e Pesquisa Sao Lucas - IEP HEMOMED
  • Instituto D'Or de Pesquisa e Ensino (IDOR)
  • Casa de Saude Santa Marcelina - Hospital Santa Marcelina
  • Fakultni nemocnice Ostrava
  • Fakultni nemocnice Kralovske Vinohrady
  • General University Hospital in Prague
  • Attikon University General Hospital of Attica
  • University Hospital of Ioannina
  • G.Papanikolaou
  • Healthcare Global (HCG) Hospital
  • American Oncology Institute (Cancer Treatment Hospital) - Hyderabad
  • Bhagwan Mahaveer Cancer Hospital & Research Centre
  • HCG cancer center
  • Tata Medical Center
  • AMRI Hospital, Mukundapur
  • Deenanath Mangeshkar Hospital and Research Centre
  • Synergy Superspeciality Hospital
  • Hospital Ampang
  • Hospital Sultanah Aminah
  • Hospital Queen Elizabeth
  • University Malaya Medical Centre
  • Subang Jaya Medical Centre
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  • Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Szpital Specjalistyczny im Jędrzeja Śniadeckiego w Nowym Saczu
  • SPZOZ Ministerstwa Spraw Wewnętrznych z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
  • Centrum Medyczne Pratia Poznan
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 PUM im. prof. Tadeusza Sokołowskiego w Szczecinie
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
  • Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
  • Auxilio Mutuo Cancer Center
  • Spitalul Clinic Coltea
  • Ovidius Clinical Hospital OCH
  • Hosp. Reina Sofia
  • Hosp. Univ. Infanta Leonor
  • Clinica Univ. de Navarra
  • Hosp. Quiron Madrid Pozuelo
  • Hosp. Clinico Univ. de Salamanca
  • Falu Lasarett Medicinkliniken Falun
  • Sunderby Sjukhus
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • China Medical University Hospital
  • Chi Mei Medical Center - Liu Ying
  • National Taiwan University Hospital
  • King Chulalongkorn Memorial Hospital
  • Phramongkutklao Hospital and Medical College
  • Ramathibodi Hospital
  • Siriraj Hospital
  • Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine
  • Srinagarind Hospital
  • Ankara Bilkent Sehir Hastanesi
  • Ondokuz Mayis Universitesi Tip Fakultesi
  • Trakya University Medical Faculty
  • Medipol Mega University Hospital
  • Istanbul University
  • Ege Universitesi Tip Fakultesi
  • Sakarya Egitim Ve Arastırma Hastanesi Korucuk Kampus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 2: Treatment Arm A1 (Rituximab plus Ibrutinib)

Phase 2: Treatment Arm A2 (Rituximab plus Ibrutinib)

Phase 2: Treatment Arm A3 (Rituximab plus Ibrutinib)

Phase 2: Treatment Arm B (Rituximab plus Lenalidomide or Bortezomib)

Arm Description

Participants will receive rituximab 375 milligrams per meter square (mg/m^2) intravenously (IV) on Day 1 of Cycles 1 to 6 with ibrutinib 560 milligrams (mg) orally, once daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days).

Participants will receive rituximab 375 mg/m^2 IV on Day 1 of Cycles 1 to 6 with ibrutinib 420 mg orally, once daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days).

Participants will receive rituximab 375 mg/m^2 IV on Day 1 of Cycles 1 to 6 with ibrutinib 140 mg orally, twice daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days).

Participants will receive rituximab 375 mg/m^2 IV on Day 1 of Cycles 1 to 6 (each cycle length is 21 or 28 days) with physician's choice of either lenalidomide 20 mg orally, once daily from Day 1 through Day 21 of 28-day cycle or bortezomib 1.3 mg/m^2 IV or subcutaneously (SC) on Days 1, 4, 8 and 11 of a 21-day cycle until disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events (AEs) that Resulted in Discontinuation of Treatment, Severe AE, or Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE defined as results in death, is life-threatening (the participant was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is Medically Important.
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Number of participants with abnormalities in clinical laboratory parameters (hematology and serum chemistry) will be reported.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
Collaborators
Pharmacyclics LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT05564052
Brief Title
A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma
Acronym
VEGA
Official Title
A Randomized, Controlled, Open-label, Multicenter, Inferentially Seamless Phase 2/3 Study of Ibrutinib in Combination With Rituximab Versus Physician's Choice of Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab in Participants With Relapsed or Refractory Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 15, 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment.
Detailed Description
Mantle cell lymphoma (MCL) is an uncommon and incurable clinicopathologic subtype of B-cell non-Hodgkin Lymphoma (NHL). Ibrutinib is a first-in-class potent, orally administered, covalently-binding small molecule inhibitor of Bruton's tyrosine kinase (BTKi) for the treatment of B-cell malignancies and chronic graft-versus-host disease. The primary hypothesis of the study is to provide continued access to treatment for participants who continue to benefit from treatment. The study will include a screening phase (up to 30 days prior to randomization), a treatment phase (from randomization until study treatment discontinuation). safety assessments include adverse events (AEs), serious adverse events (SAEs), clinical laboratory tests, vital signs, electrocardiogram (ECG), physical examination. The Phase 2 exploratory objectives and endpoints of characterization of pharmacokinetic and pharmacodynamic of ibrutinib may continue to be evaluated using blood samples already collected. The total duration of the study will be up to 2 years 1 month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Mantle-Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 2: Treatment Arm A1 (Rituximab plus Ibrutinib)
Arm Type
Experimental
Arm Description
Participants will receive rituximab 375 milligrams per meter square (mg/m^2) intravenously (IV) on Day 1 of Cycles 1 to 6 with ibrutinib 560 milligrams (mg) orally, once daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days).
Arm Title
Phase 2: Treatment Arm A2 (Rituximab plus Ibrutinib)
Arm Type
Experimental
Arm Description
Participants will receive rituximab 375 mg/m^2 IV on Day 1 of Cycles 1 to 6 with ibrutinib 420 mg orally, once daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days).
Arm Title
Phase 2: Treatment Arm A3 (Rituximab plus Ibrutinib)
Arm Type
Experimental
Arm Description
Participants will receive rituximab 375 mg/m^2 IV on Day 1 of Cycles 1 to 6 with ibrutinib 140 mg orally, twice daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days).
Arm Title
Phase 2: Treatment Arm B (Rituximab plus Lenalidomide or Bortezomib)
Arm Type
Experimental
Arm Description
Participants will receive rituximab 375 mg/m^2 IV on Day 1 of Cycles 1 to 6 (each cycle length is 21 or 28 days) with physician's choice of either lenalidomide 20 mg orally, once daily from Day 1 through Day 21 of 28-day cycle or bortezomib 1.3 mg/m^2 IV or subcutaneously (SC) on Days 1, 4, 8 and 11 of a 21-day cycle until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
JNJ-54179060, IMBRUVICA, PCI-32765
Intervention Description
Ibrutinib capsules will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide capsules will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab will be administered IV.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Bortezomib will be administered either intravenously or subcutaneously.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs) that Resulted in Discontinuation of Treatment, Severe AE, or Serious Adverse Events (SAEs)
Description
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE defined as results in death, is life-threatening (the participant was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is Medically Important.
Time Frame
Up to 6 months
Title
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Description
Number of participants with abnormalities in clinical laboratory parameters (hematology and serum chemistry) will be reported.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 1 prior treatment regimen for mantle cell lymphoma (MCL) excluding inhibitor of Bruton's tyrosine kinase (BTKi) Documented disease progression or relapse following the last anti-MCL treatment At least 1 measurable site of disease on cross-sectional imaging that is greater than or equal to (>=) 2.0 centimeters (cm) in the longest diameter and measurable in 2 perpendicular dimensions per computed tomography (CT) Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 Exclusion Criteria: Prior therapy with ibrutinib or other BTK inhibitor Prior treatment with both lenalidomide and bortezomib. Prior treatment with only 1 of these therapies is allowed Major surgery within 4 weeks of randomization Concurrent enrollment in another therapeutic investigational study Known central nervous system lymphoma History of stroke or intracranial hemorrhage within 6 months prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
City
Brasilia
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Ynova Pesquisa Clinica
City
Florianopolis
ZIP/Postal Code
88020-210
Country
Brazil
Facility Name
Liga Norte Riograndense Contra O Cancer
City
Natal
ZIP/Postal Code
59062-000
Country
Brazil
Facility Name
Complexo Hospitalar de Niterói
City
Niteroi
ZIP/Postal Code
24020-096
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
City
Ribeirao Preto
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Oncoclínicas Rio de Janeiro S.A.
City
Rio de Janeiro
ZIP/Postal Code
22250-905
Country
Brazil
Facility Name
Instituto de Ensino e Pesquisa Sao Lucas - IEP HEMOMED
City
Sao Paulo
ZIP/Postal Code
01236-030
Country
Brazil
Facility Name
Instituto D'Or de Pesquisa e Ensino (IDOR)
City
Sao Paulo
ZIP/Postal Code
04501-000
Country
Brazil
Facility Name
Casa de Saude Santa Marcelina - Hospital Santa Marcelina
City
Sao Paulo
ZIP/Postal Code
08270-120
Country
Brazil
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
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
General University Hospital in Prague
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Attikon University General Hospital of Attica
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
University Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45110
Country
Greece
Facility Name
G.Papanikolaou
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Healthcare Global (HCG) Hospital
City
Bangalore
ZIP/Postal Code
560027
Country
India
Facility Name
American Oncology Institute (Cancer Treatment Hospital) - Hyderabad
City
Hyderabad
ZIP/Postal Code
500019
Country
India
Facility Name
Bhagwan Mahaveer Cancer Hospital & Research Centre
City
Jaipur
ZIP/Postal Code
302017
Country
India
Facility Name
HCG cancer center
City
Jaipur
ZIP/Postal Code
302020
Country
India
Facility Name
Tata Medical Center
City
Kolkata
ZIP/Postal Code
700156
Country
India
Facility Name
AMRI Hospital, Mukundapur
City
Mukundapur
ZIP/Postal Code
700099
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Synergy Superspeciality Hospital
City
Rajkot
ZIP/Postal Code
360005
Country
India
Facility Name
Hospital Ampang
City
Ampang
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Hospital Sultanah Aminah
City
Johor Bharu
ZIP/Postal Code
80100
Country
Malaysia
Facility Name
Hospital Queen Elizabeth
City
Kota Kinabalu
ZIP/Postal Code
88586
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Subang Jaya Medical Centre
City
Subang Jaya
ZIP/Postal Code
47500
Country
Malaysia
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
City
Brzozów
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Szpital Specjalistyczny im Jędrzeja Śniadeckiego w Nowym Saczu
City
Nowy Sącz
ZIP/Postal Code
33-300
Country
Poland
Facility Name
SPZOZ Ministerstwa Spraw Wewnętrznych z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Centrum Medyczne Pratia Poznan
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 PUM im. prof. Tadeusza Sokołowskiego w Szczecinie
City
Szczecin
ZIP/Postal Code
71252
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
City
Wałbrzych
ZIP/Postal Code
58-309
Country
Poland
Facility Name
Auxilio Mutuo Cancer Center
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Spitalul Clinic Coltea
City
Bucuresti
ZIP/Postal Code
030167
Country
Romania
Facility Name
Ovidius Clinical Hospital OCH
City
Ovidiu
ZIP/Postal Code
905900
Country
Romania
Facility Name
Hosp. Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hosp. Univ. Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hosp. Quiron Madrid Pozuelo
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Falu Lasarett Medicinkliniken Falun
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Name
Sunderby Sjukhus
City
Luleå
ZIP/Postal Code
97180
Country
Sweden
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404327
Country
Taiwan
Facility Name
Chi Mei Medical Center - Liu Ying
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Phramongkutklao Hospital and Medical College
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine
City
ChiangMai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Ankara Bilkent Sehir Hastanesi
City
Ankara Sehir Hastanesi
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Ondokuz Mayis Universitesi Tip Fakultesi
City
Atakum
ZIP/Postal Code
55270
Country
Turkey
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Medipol Mega University Hospital
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Istanbul University
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Sakarya Egitim Ve Arastırma Hastanesi Korucuk Kampus
City
Sakarya
ZIP/Postal Code
54290
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma

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