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Mantle Cell Lymphoma (MCL) is a form of Non-Hodgkin Lymphoma (NHL - cancer of the lymphatic system in blood) where cells from outer edge of the lymph nodes, called mantle zone become cancerous. In Japan, MCL accounts for about 3% of all NHL cases. Symptoms of MCL may include enlarged lymph nodes, stomach pain, fever, night sweats, and weight loss. Currently, MCL is not curable with standard therapies. The purpose of this study is to evaluate the safety, efficacy, and effect of venetoclax in combination with ibrutinib on best overall response of complete response in participants with relapsed (return of disease) or refractory (not responding to treatment) (R/R) MCL.
Venetoclax is an investigational drug being developed for the treatment of MCL. Ibrutinib is a drug approved for the treatment of MCL. Participants will receive venetoclax (increasing doses) and ibrutinib (fixed dose) for approximately 104 weeks, followed by ibrutinib alone. Adult participants with R/R MCL will be enrolled. Around 12 participants will be enrolled in Japan.
Participants will receive oral venetoclax tablet and oral ibrutinib capsule for 104 weeks. After 104 weeks, participants will receive ibrutinib once daily until their disease progresses, or they cannot tolerate the medication, or until they do not want to participate in the study.
There may be a higher treatment burden for participants in this study compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, bone marrow biopsies, checking for side effects, and completing questionnaires.
Safety and efficacy data through 09 February 2022 are included in the interim analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrutinib + Venetoclax | Experimental | Participants will receive Ibrutinib Dose A + Venetoclax in various doses until a target dose is reached, for up to 104 weeks, followed by Ibrutinib monotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug | Capsule; Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Best Overall Response of Complete Response (CR), as Assessed by the Independent Review Committee (IRC) | Complete response rate (CRR), defined as the percentage of participants achieving a best overall response of complete response (CR) per the Revised Criteria for Response Assessment for Malignant Lymphoma following the Lugano classification (Cheson 2014), assessed by an Independent Review Committee (IRC). | Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Best Overall Response of CR or PR, as Assessed by the IRC | Overall Response Rate (ORR), defined as the percentage of participants with a best overall response of CR or PR, per the Revised Criteria for Response Assessment for Malignant Lymphoma, assessed by an Independent Review Committee (IRC). | Week 104 |
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Inclusion Criteria:
Exclusion Criteria:
Prior therapy with ibrutinib or other Bruton Tyrosine Kinase (BTK) inhibitors.
History of other malignancies, except:
History or current evidence of central nervous system lymphoma.
Treatment with any of the following within 7 days prior to the first dose of study drug:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHO Nagoya Medical Center /ID# 221958 | Nagoya | Aichi-ken | 460-0001 | Japan | ||
| Aichi Cancer Center Hospital /ID# 221565 |
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| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
The Full Analysis Set (FAS) included all participants who received at least one dose of study drug and was used for all efficacy analyses (except for those based on IRC assessment), safety, and baseline analyses (N=13). The Per-protocol (PP) population excluded participants with non-evaluable disease at baseline (based on IRC assessment). PP population was used for IRC-assessed endpoints (N=12).
A total of 13 participants were enrolled across 12 sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibrutinib + Venetoclax | Participants received Ibrutinib 560 mg once daily (QD) + Venetoclax starting at 20 mg QD, gradually ramped up over 5 weeks to a target dose of 400 mg QD. Ibrutinib 560 mg QD + Venetoclax 400 mg QD was continued for up to 104 weeks, followed by 560 mg QD Ibrutinib monotherapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2023 | Oct 10, 2024 |
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| Venetoclax | Drug | Tablet; Oral |
|
|
| Percentage of Participants Achieving Best Overall Response of CR as Assessed by the Investigator |
Best overall response of CR is defined as the percentage of participants achieving a best overall response of CR for the venetoclax and ibrutinib combination, as assessed by the investigator per the Revised Criteria for Response Assessment for Malignant Lymphoma . |
| Week 104 |
| Percentage of Participants Achieving Best Overall Response of CR or PR, as Assessed by the Investigator | Best overall response of CR or PR will be evaluated using ORR. The ORR is defined as the percentage of participants with a best overall response of CR or PR, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the investigator. | Week 104 |
| Duration of Response (DOR) for Participants Who Achieved a Best Overall Response of CR or PR, as Assessed by the Investigator | DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the investigator. | Week 104 |
| DOR for Participants Who Achieved a Best Overall Response of CR or PR, as Assessed by the IRC | DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the IRC. | Week 104 |
| Undetectable Minimal Residual Disease (uMRD) in Participants Who Achieve a Best Overall Response of CR as Assessed by the Investigator. | MRD rate is defined as the percentage of participants with uMRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the investigator. | Week 104 |
| uMRD in Participants Who Achieve a Best Overall Response of CR as Assessed by IRC. | MRD rate is defined as the percentage of participants with uMRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the IRC. | Week 104 |
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of the first dose of study drug (venetoclax or ibrutinib) to the date of investigator-assessed disease progression, using the Revised Response Criteria for Response Assessment for Malignant Lymphoma, or death from any cause, whichever occurs first. | Week 104 |
| Overall Survival (OS) | OS is defined as the time from the date of the first dose of the study drug (venetoclax or ibrutinib) to death from any cause. | Week 104 |
| Nagoya |
| Aichi-ken |
| 464-8681 |
| Japan |
| Kyushu University Hospital /ID# 223299 | Fukuoka | Fukuoka | 812-8582 | Japan |
| Hokkaido University Hospital /ID# 221662 | Sapporo | Hokkaido | 060-8648 | Japan |
| Kobe City Medical Center General Hospital /ID# 221744 | Kobe | Hyōgo | 650-0047 | Japan |
| National Hospital Organization Mito Medical Center /ID# 224912 | Higashi Ibaraki-gun | Ibaraki | 311-3193 | Japan |
| Ishikawa Prefectural Central Hospital /ID# 224896 | Kanazawa | Ishikawa-ken | 920-8530 | Japan |
| Tohoku University Hospital /ID# 221975 | Sendai | Miyagi | 9808574 | Japan |
| Duplicate_Okayama University Hospital /ID# 221623 | Okayama | Okayama-ken | 700-8558 | Japan |
| Saitama Medical Center /ID# 224910 | Kawagoe-shi | Saitama | 350-8550 | Japan |
| National Cancer Center Hospital /ID# 221812 | Chuo-ku | Tokyo | 104-0045 | Japan |
| Yamagata University Hospital /ID# 221573 | Yamagata | Yamagata | 990-9585 | Japan |
| COMPLETED |
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| NOT COMPLETED |
|
|
Full Analysis Set (N=13)
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibrutinib + Venetoclax | Participants received Ibrutinib 560 mg QD + Venetoclax starting at 20 mg QD, gradually ramped up over 5 weeks to a target dose of 400 mg QD. Ibrutinib 560 mg QD + Venetoclax 400 mg QD was continued for up to 104 weeks, followed by Ibrutinib monotherapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Best Overall Response of Complete Response (CR), as Assessed by the Independent Review Committee (IRC) | Complete response rate (CRR), defined as the percentage of participants achieving a best overall response of complete response (CR) per the Revised Criteria for Response Assessment for Malignant Lymphoma following the Lugano classification (Cheson 2014), assessed by an Independent Review Committee (IRC). | Per-Protocol Population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 13 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Best Overall Response of CR or PR, as Assessed by the IRC | Overall Response Rate (ORR), defined as the percentage of participants with a best overall response of CR or PR, per the Revised Criteria for Response Assessment for Malignant Lymphoma, assessed by an Independent Review Committee (IRC). | Not Posted | Jun 2026 | Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Best Overall Response of CR as Assessed by the Investigator | Best overall response of CR is defined as the percentage of participants achieving a best overall response of CR for the venetoclax and ibrutinib combination, as assessed by the investigator per the Revised Criteria for Response Assessment for Malignant Lymphoma . | Not Posted | Jun 2026 | Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Best Overall Response of CR or PR, as Assessed by the Investigator | Best overall response of CR or PR will be evaluated using ORR. The ORR is defined as the percentage of participants with a best overall response of CR or PR, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the investigator. | Not Posted | Jun 2026 | Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) for Participants Who Achieved a Best Overall Response of CR or PR, as Assessed by the Investigator | DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the investigator. | Not Posted | Jun 2026 | Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DOR for Participants Who Achieved a Best Overall Response of CR or PR, as Assessed by the IRC | DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the IRC. | Not Posted | Jun 2026 | Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Undetectable Minimal Residual Disease (uMRD) in Participants Who Achieve a Best Overall Response of CR as Assessed by the Investigator. | MRD rate is defined as the percentage of participants with uMRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the investigator. | Not Posted | Jun 2026 | Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | uMRD in Participants Who Achieve a Best Overall Response of CR as Assessed by IRC. | MRD rate is defined as the percentage of participants with uMRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the IRC. | Not Posted | Jun 2026 | Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS is defined as the time from the date of the first dose of study drug (venetoclax or ibrutinib) to the date of investigator-assessed disease progression, using the Revised Response Criteria for Response Assessment for Malignant Lymphoma, or death from any cause, whichever occurs first. | Not Posted | Jun 2026 | Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from the date of the first dose of the study drug (venetoclax or ibrutinib) to death from any cause. | Not Posted | Jun 2026 | Week 104 | Participants |
All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Venetoclax + Ibrutinib | Participants received Ibrutinib 560 mg QD + Venetoclax starting at 20 mg QD, gradually ramped up over 5 weeks to a target dose of 400 mg QD. Ibrutinib 560 mg QD + Venetoclax 400 mg QD was continued for up to 104 weeks, followed by Ibrutinib monotherapy. | 2 | 13 | 2 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| CONJUNCTIVAL HAEMORRHAGE | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| CHEILITIS | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| GENERALISED OEDEMA | General disorders | MedDRA 24.1 | Systematic Assessment |
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| INJECTION SITE PAIN | General disorders | MedDRA 24.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 24.1 | Systematic Assessment |
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| MUCOSAL INFLAMMATION | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 24.1 | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
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| BODY TINEA | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| CANDIDA INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| IMPETIGO | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| PERIODONTITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| ANOGENITAL WARTS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| PHARYNGEAL ERYTHEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| RESPIRATORY TRACT OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| ERYTHEMA MULTIFORME | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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| VASCULAR PAIN | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 16, 2022 | Oct 10, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
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| ID | Term |
|---|---|
| C551803 | ibrutinib |
| C579720 | venetoclax |
Not provided
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|