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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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This is a Phase 1b/2, open-label, non-randomized multicenter study to assess the safety and efficacy of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL).
This is a Phase 1b, open-label, non-randomized multicenter study conducted in 2 parts. Part 1, will determine the MTD of the combination of ibrutinib, lenalidomide and DA-EPOCH-R in subjects with DLBCL.
Ibrutinib will be administered at a fixed dose of 560 mg and lenalidomide will be dose-escalated. DA-EPOCH-R will be given at standard doses.
For Part 2, the MTD determined in Part 1 will be the dose used for all subjects. If no MTD is identified, then subjects in Part 2 will be treated with the maximum administered doses (MAD, treatment doses from dose Level 4).
The primary objective for Part 2 is to determine the ORR of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with ABC DLBCL as analyzed by gene expression profiling when treated at recommended phase 2 dose (RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Level 1 | Experimental | Ibrutinib 560 mg PO + DA-EPOCH-R |
|
| Part 1: Dose Level 2 | Experimental | Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R |
|
| Part 1: Dose Level 3 | Experimental | Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R |
|
| Part 1: Dose Level 4 | Experimental | Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R |
|
| Part 2: RP2D | Experimental | Recommended Phase 2 Dose(RP2D): Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicities as a Measure of Safety and Tolerability | Part-1: To determine the maximum tolerated dose (MTD) of the combination of ibrutinib and lenalidomide with dose adjusted EPOCH-R | 1 year after last subjects received the first dose |
| Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy-ORR | Part 2 - Overall Response rate will be defined as the proportion of subjects who achieve either a Complete Response or a Partial Response according to the international Working Group Response Criteria for NHL as assessed by investigator. | 1 year after last subjects received the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy | Part-1: Overall Response rate (ORR) will defined as the proportion of subjects who achieve either a CR or a PR according to the international Working Group Response Criteria for NHL as assessed by investigator. | 1 year after last subjects received the first dose |
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Major inclusion criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Pathologically confirmed relapsed/refractory DLBCL
Subjects must have ≥1 measurable disease site on CT scan (≥ 1.5 cm in longest dimension).
Adequate hepatic and renal function:
Adequate hematologic function:
Must be registered into the Revlimid REMSâ„¢program and be willing to comply with the requirements of Revlimid REMSâ„¢.
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jutta Neuenburg, MD | Pharmacyclics LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SITE-1 | Duarte | California | 91010 | United States | ||
| SITE-2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33856277 | Derived | Wilson WH, Phillips T, Popplewell L, de Vos S, Chhabra S, Kimball AS, Beaupre D, Huang DW, Wright G, Kwei K, Ping J, Neuenburg JK, Staudt LM. Phase 1b/2 study of ibrutinib and lenalidomide with dose-adjusted EPOCH-R in patients with relapsed/refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2021 Sep;62(9):2094-2106. doi: 10.1080/10428194.2021.1907371. Epub 2021 Apr 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Dose Level 1 | Ibrutinib 560 mg PO + DA-EPOCH-R DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim |
| FG001 | Part 1: Dose Level 2 |
| 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 | Sep 30, 2014 | May 31, 2018 |
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| DA-EPOCH-R | Drug | Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim |
|
| Lenalidomide | Drug | Lenalidomide |
|
| Number of Subjects With Adverse Events as a Measure of Safety and Tolerability | Part 2: The frequency (number and percentage) of treatment-emergent adverse events will be reported. | 1 year after last subjects received the first dose |
| Progression Free Survival (PFS) and Overall Survival (OS) as a Measure of Efficacy | Part 2: PFS will be measured as time from first study drug administration to disease progression or death from any cause. OS will be measured from the time of first study drug administration until the date of death using Kaplan-Meier methodology. | From initial dose date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose, up to 36 months at the most. |
| Duration of Response (DOR) | Part 2: DOR will be measured from the time by which the measurement criteria are met for CR or PR until the first date by which recurrent or progressive disease is objectively documented. | From initial response date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose. |
| Los Angeles |
| California |
| 90095 |
| United States |
| SITE-10 | Orange | California | 92868 | United States |
| SITE-3 | Chicago | Illinois | 60612 | United States |
| SITE-5 | Baltimore | Maryland | 21201 | United States |
| SITE-6 | Bethesda | Maryland | 20892 | United States |
| SITE-4 | Ann Arbor | Michigan | 48109 | United States |
| SITE-8 | Albuquerque | New Mexico | 87106 | United States |
| SITE-9 | Stony Brook | New York | 11794 | United States |
| SITE-7 | Charleston | South Carolina | 29425 | United States |
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
| FG002 | Part 1: Dose Level 3 | Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim |
| FG003 | Part 1: Dose Level 4 | Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim |
| FG004 | Part 2: RP2D | Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Dose Level 1 | Ibrutinib 560 mg PO + DA-EPOCH-R DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim |
| BG001 | Part 1: Dose Level 2 | Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim |
| BG002 | Part 1: Dose Level 3 | Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim |
| BG003 | Part 1: Dose Level 4 | Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim |
| BG004 | Part 2: RP2D | Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim |
| BG005 | Total | Total of all reporting groups |
| 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 | No |
| |||||||||||||||
| Age, Continuous | Median | Full Range | 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 | Number of Participants With Dose-Limiting Toxicities as a Measure of Safety and Tolerability | Part-1: To determine the maximum tolerated dose (MTD) of the combination of ibrutinib and lenalidomide with dose adjusted EPOCH-R | Posted | Count of Participants | Participants | 1 year after last subjects received the first dose |
|
|
| |||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy-ORR | Part 2 - Overall Response rate will be defined as the proportion of subjects who achieve either a Complete Response or a Partial Response according to the international Working Group Response Criteria for NHL as assessed by investigator. | Posted | Count of Participants | Participants | 1 year after last subjects received the first dose |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy | Part-1: Overall Response rate (ORR) will defined as the proportion of subjects who achieve either a CR or a PR according to the international Working Group Response Criteria for NHL as assessed by investigator. | Posted | Count of Participants | Participants | 1 year after last subjects received the first dose |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Adverse Events as a Measure of Safety and Tolerability | Part 2: The frequency (number and percentage) of treatment-emergent adverse events will be reported. | Posted | Count of Participants | Participants | 1 year after last subjects received the first dose |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) and Overall Survival (OS) as a Measure of Efficacy | Part 2: PFS will be measured as time from first study drug administration to disease progression or death from any cause. OS will be measured from the time of first study drug administration until the date of death using Kaplan-Meier methodology. | Posted | Median | Full Range | Months | From initial dose date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose, up to 36 months at the most. |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Part 2: DOR will be measured from the time by which the measurement criteria are met for CR or PR until the first date by which recurrent or progressive disease is objectively documented. | Posted | Median | Full Range | Months | From initial response date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose. |
|
|
3 years
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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 | Part 1: Dose Level 1 | Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 0 (PO) DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim | 3 | 3 | 3 | 3 | 3 | 3 |
| EG001 | Part 1: Dose Level 2 | Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 15 (PO) DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim | 3 | 3 | 3 | 3 | 3 | 3 |
| EG002 | Part 1: Dose Level 3 | Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 20 (PO) DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim | 3 | 3 | 3 | 3 | 3 | 3 |
| EG003 | Part 1: Dose Level 4 | Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 25 mg (PO) DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim | 5 | 6 | 5 | 6 | 6 | 6 |
| EG004 | All Subjects Treated at RP2D | Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim | 3 | 26 | 19 | 26 | 26 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Diffuse alveolar damage | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Immunoglobulins decreased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hyperchloraemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Magnesium deficiency | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Renal haemorrhage | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Jugular vein distension | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Pharmacyclics, LLC | 408-774-0330 | Clinical_Directors@pcyc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2017 | May 31, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| 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
Not provided
| ID | Term |
|---|---|
| C551803 | ibrutinib |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
| OG004 | Part 1: All Treated | Ibrutinib 560 mg (PO) +lenalidomide 0,15, 20, and 25 mg (PO) + DA-EPOCH-R DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim |
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