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| Name | Class |
|---|---|
| Janssen-Cilag, S.A. | INDUSTRY |
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Multicentric phase II trial to evaluate efficacy and safety of ibrutinib in combination with rituximab, gemcitabine, oxaliplatin and dexamethasone followed by Ibrutinib maintenance in patients with refractory/relapsed non-GCB DLBCL non candidates to autologous stem-cell transplantation (ASCT) An extensive biological study will be conducted in order to further characterize this population of DLBCL patients and correlate the response obtained with the biological profile of the tumor.
The use of highly effective rituximab-containing therapy for treating diffuse large B-cell lymphoma (DLBCL) makes it more difficult to salvage relapsed or refractory patients. In addition, patients with advanced age or significant comorbidities, who are consequently not candidates for high-dose consolidative therapy, have a very poor prognosis. Prospective studies investigating new salvage regimens are essential.
The combination of rituximab, gemcitabine and oxaliplatin (R-GEMOX) is an effective salvage regimen for patients with relapsing or refractory DLBCL, with a favourable toxicity profile for unfit and/or elderly patients. Ibrutinib, an oral Bruton's tyrosine kinase inhibitor, is a potent killer of ABC DLBCL cell lines in vitro and in xenografts.
It is expected that the combination of ibrutinib with R-GEMOX-Dexa could be effective and well tolerated. Thus, it is proposed an open-label, non-randomized, multicentre, phase II trial, to investigate the safety and efficacy of the combination of ibrutinib with rituximab, gemcitabine, oxaliplatine and dexamethasone followed by ibrutinib maintenance as salvage therapy for patients with relapsed or refractory non-GCB DLBCL non-candidates to stem cell transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrutinib -R-GEMOX-Dexa | Experimental | Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to: Induction phase:
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles. Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response (OR) Rate | Overall Response (OR) rate (complete remission + partial response) measured by PET(Positron Emission Tomography)/CT image scan. OR will be assessed by Lugano Classification: Revised Criteria for Response Assessment. | Treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| CR Rate During Induction and Maintenance Phases. | Complete treatment responses evaluation during 21-35 days after initiation of 6 or 8 cycle of study treatment (depend of treatment responses obtained from cycle 4) and 30 days after end of study treatment which can be occurred after 2 years and 4 months | Complete treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 months |
Not provided
Inclusion Criteria:
Subjects with confirmed histologically diagnosis of diffuse large B-cell lymphoma.
Subjects must be 18 years of age or older.
Non-germinal center B-cell-like (GCB) subtype according to Hans algorithm (local laboratories).
-A central review will be performed for confirmation of the germinal center B-cell-like, however even when negative results are reported, the patient will still be part of the study if clinical benefit after cycle 4 is documented (stable disease, partial response and complete response).
Relapsed or refractory disease after:
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Baseline FDG-PET scan demonstrating positive lesions (Deauville 4 or 5) compatible with CT defined anatomical tumor sites.
Hematology values must be within the following limits:
Biochemical values within the following limits:
Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing and able to participate in the study.
Exclusion Criteria:
Prior malignancy other than DLBCL, with the exception of adequately treated basal cell or squamous cell skin tumor, in situ cervical cancer, or other tumor from which the patient has been disease free for at least 2 years or which will not limit survival to < 2 years (Note: these cases must be discussed with the Principal Investigator).
Candidates to autologous stem cell transplant.
- Young patients with more than a previous line and refractory could be considered as not suitable for autologous stem cell transplant and, therefore, are eligible for this study.
Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety,interfere with the absorption or metabolism of ibrutinib, or put the study outcomes at undue risk.
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis,symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
Treatment with any immunotherapy, chemotherapy, radiotherapy, or experimental therapy within 3 weeks before first dose of study drug.
Prior treatment with ibrutinib or other BTK inhibitors.
Central nervous system (CNS) involvement by lymphoma.
History of stroke or intracranial hemorrhage within 6 months prior to randomization.
Requires anticoagulation with warfarin or equivalent Vitamin K antagonists.
Requires treatment with strong CYP3A inhibitors.
Grade ≥2 toxicity (other than alopecia) related to prior anticancer therapy including radiation.
Known history of human immunodeficiency virus (HIV), active hepatitis C virus (HCV) (HCV; RNA polymerase chain reaction [PCR]-positive) or active Hepatitis B virus (HBV; DNA PCR-positive) infection or any uncontrolled active systemic infection requiring IV antibiotics. Subjects with PCR-negative HBV are permitted in the study.
Major surgery within 4 weeks before first dose of study drug.
Vaccinated with live, attenuated vaccines within 4 weeks of randomization.
Pregnancy or lactation
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| Name | Affiliation | Role |
|---|---|---|
| Dolores Caballero, MD | University of Salamanca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Son Espases | Palma | Balearic Islands | 07120 | Spain | ||
| Hospital Especialidades |
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64 patients from 15 different hospitals were registered.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ibrutinib -R-GEMOX-Dexa | Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to: Induction phase:
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles. Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity. Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years). Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles. Gemcitabine: Gemcitabine 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days. Oxaliplatin: Oxaliplatin 100 mg/m2 (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days. Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Oct 21, 2016 |
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| Rituximab | Drug | Rituximab 375 mg/m2 IV day 1 during 4 cycles. |
|
| Gemcitabine | Drug | Gemcitabine 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days. |
|
| Oxaliplatin | Drug | Oxaliplatin 100 mg/m2 (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days. |
|
| Dexamethasone | Drug | Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days. |
|
| Response Duration | Response duration defined as the time from the documentation of tumor response to disease progression or death, in the event of no documented recurrence, or start of a new anti - lymphoma treatment because of refractory or persistent disease. | Response duration will be evaluated at any time during the study when tumor response is documented or after end of study treatment which can be occurred after 2 years and 4 months. |
| Progression Free Survival | Progression free survival defined as the time between start of treatment and the first documentation of recurrence, progression, or death in the event of no documented recurrence, or start of a new anti - lymphoma treatment, due a refractory or persistent disease. Progression is defined using Lugano Classification for response assessment for Non-Hodgkin Lymphoma, defined as Score of 4 or 5 with an increase in uptake intensity over baseline period for Individual lymph nodes/target lymph node masses; New areas of FDG avidity consistent with lymphoma at mid- or end-of-treatment assessment for Extranodal injuries; new injuries; New or recurrent areas of FDG avidity in bone marrow. | Progression free survival will be evaluated at any time during the study when first documentation of recurrence, progression, or death or after end of study treatment which can be occurred after 2 years and 4 months |
| Event-free Survival | Event-free survival defined as the time between start of treatment and the first documentation of adverse events and serious adverse events graded according to NCI CTCAE v4.0 | 2 years and 4 months. |
| Overall Survival | Overall survival is defined as the time between the start of treatment and death from any cause. Patients that are withdrawn from the trial or lost of follow-up, will be censored with the date of last contact. Patients who are still alive at the end of the study will be censored at that time. | 2 years |
| Percentage of Participants That Present Treatment-Related Adverse Events Oxaliplatin and Dexamethasone | Safety and tolerability will be assessed during any phase of study treatment and 30 days after end of study treatment which can be occurred after 2 years and 4 months and will be classified according to the Common Toxicity CNC | 2 years and 4 months |
| Jerez de la Frontera |
| Cádiz |
| 11407 |
| Spain |
| Hospital Universitario Donostia | Donostia / San Sebastian | Guipúzcoa | 20080 | Spain |
| Hospital de Navarra | Pamplona | Navarre | 31008 | Spain |
| Complexo Hospitalario Universitario de Vigo | Vigo | Pontevedra | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital ClÃnic de Barcelona | Barcelona | 08036 | Spain |
| Complejo Hospitalario de Jaén | Jaén | 23007 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| MD Anderson Cancer Center | Madrid | 28033 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital General Universitario Morales Meseguer | Murcia | 30008 | Spain |
| Hospital Universitario Virgen del RocÃo | Seville | 41013 | Spain |
| Hospital ClÃnic Universitari de València | Valencia | 46010 | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| Hospital ClÃnico Universitario de Valladolid | Valladolid | 47005 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ibrutinib -R-GEMOX-Dexa | Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to: Induction phase:
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles. Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity. Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years). Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles. Gemcitabine: Gemcitabine 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days. Oxaliplatin: Oxaliplatin 100 mg/m2 (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days. Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| ECOG-PS | Patients staged according to European Eastern Cooperative Group Performance Status scale from 0 (Fully active, able to carry on all pre-disease performance without restriction) to 5 (Dead) | Count of Participants | Participants |
| |||||||||||||||||
| DLBCL type | Diffuse large B Cell subtype classification | Count of Participants | Participants |
| |||||||||||||||||
| Previous lines of treatment | Median | Full Range | Previous lines of treatment |
| |||||||||||||||||
| International prognostic index (IPI) | International Prognostic Index (R-IPI) was developed to predict the outcome of individuals receiving rituximab with chemotherapy. The score is able to differentiate patients into three groups, all of who have survival >50%. From better to worse outcome: 0-1 for very good, 2-3 for good and 4-5 to poor. | Count of Participants | Participants |
| |||||||||||||||||
| Disease stage at diagnosis | Diffuse large B-cell lymphoma stage at diagnosis. The stage classification was made according to Lugano classification, going from better (I) to worse (IV). | Count of Participants | Participants |
| |||||||||||||||||
| LDH levels | Lactate dehydrogenase levels | Count of Participants | 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 | Overall Response (OR) Rate | Overall Response (OR) rate (complete remission + partial response) measured by PET(Positron Emission Tomography)/CT image scan. OR will be assessed by Lugano Classification: Revised Criteria for Response Assessment. | Posted | Count of Participants | Participants | Treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | CR Rate During Induction and Maintenance Phases. | Complete treatment responses evaluation during 21-35 days after initiation of 6 or 8 cycle of study treatment (depend of treatment responses obtained from cycle 4) and 30 days after end of study treatment which can be occurred after 2 years and 4 months | Posted | Count of Participants | Participants | Complete treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 months |
| |||||||||||||||||||||||||||||
| Secondary | Response Duration | Response duration defined as the time from the documentation of tumor response to disease progression or death, in the event of no documented recurrence, or start of a new anti - lymphoma treatment because of refractory or persistent disease. | Posted | Median | Full Range | months | Response duration will be evaluated at any time during the study when tumor response is documented or after end of study treatment which can be occurred after 2 years and 4 months. |
| ||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Progression free survival defined as the time between start of treatment and the first documentation of recurrence, progression, or death in the event of no documented recurrence, or start of a new anti - lymphoma treatment, due a refractory or persistent disease. Progression is defined using Lugano Classification for response assessment for Non-Hodgkin Lymphoma, defined as Score of 4 or 5 with an increase in uptake intensity over baseline period for Individual lymph nodes/target lymph node masses; New areas of FDG avidity consistent with lymphoma at mid- or end-of-treatment assessment for Extranodal injuries; new injuries; New or recurrent areas of FDG avidity in bone marrow. | Posted | Median | 95% Confidence Interval | months | Progression free survival will be evaluated at any time during the study when first documentation of recurrence, progression, or death or after end of study treatment which can be occurred after 2 years and 4 months |
| ||||||||||||||||||||||||||||
| Secondary | Event-free Survival | Event-free survival defined as the time between start of treatment and the first documentation of adverse events and serious adverse events graded according to NCI CTCAE v4.0 | There was 1 (1.6%) patient that ended treatment due to the onset of a new neoplasia but did not require a new therapeutic strategy and was not considered as an EFS event. | Posted | Median | 95% Confidence Interval | months | 2 years and 4 months. |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the time between the start of treatment and death from any cause. Patients that are withdrawn from the trial or lost of follow-up, will be censored with the date of last contact. Patients who are still alive at the end of the study will be censored at that time. | Posted | Median | 95% Confidence Interval | months | 2 years |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Present Treatment-Related Adverse Events Oxaliplatin and Dexamethasone | Safety and tolerability will be assessed during any phase of study treatment and 30 days after end of study treatment which can be occurred after 2 years and 4 months and will be classified according to the Common Toxicity CNC | percentage of patients that present AE related to the treatment | Posted | Count of Participants | Participants | 2 years and 4 months |
|
2 years and 4 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibrutinib -R-GEMOX-Dexa | Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to: Induction phase:
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles. Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity. Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years). Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles. Gemcitabine: Gemcitabine 1000 mg/msq IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days. Oxaliplatin: Oxaliplatin 100 mg/msq (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days. Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days. | 46 | 64 | 33 | 64 | 63 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea - Grade 3 | Gastrointestinal disorders | NCI-CTCAE | Systematic Assessment |
| |
| Fever - Grade 3 | General disorders | NCI-CTCAE | Systematic Assessment |
| |
| Abdominal pain - Grade 3 | Gastrointestinal disorders | NCI-CTCAE | Systematic Assessment |
| |
| Akathisia - Grade 3 | Nervous system disorders | NCI-CTCAE | Systematic Assessment |
| |
| Anemia - Grade 3 | Blood and lymphatic system disorders | NCI-CTCAE | Systematic Assessment |
| |
| Back Pain - Grade 3 | Musculoskeletal and connective tissue disorders | NCI-CTCAE | Systematic Assessment |
| |
| Confusion - Grade 3 | Nervous system disorders | NCI-CTCAE | Systematic Assessment |
| |
| Diarrhoea - Grade 2 | Gastrointestinal disorders | NCI-CTCAE | Systematic Assessment |
| |
| Dysphagia - Grade 2 | Gastrointestinal disorders | NCI-CTCAE | Systematic Assessment |
| |
| Fatigue - Grade 3 | General disorders | NCI-CTCAE | Systematic Assessment |
| |
| Febrile neutropenia - Grade 2 | Blood and lymphatic system disorders | NCI-CTCAE | Systematic Assessment |
| |
| Febrile neutropenia - Grade 3 | Blood and lymphatic system disorders | NCI-CTCAE | Systematic Assessment |
| |
| Fever - Grade 1 | General disorders | NCI-CTCAE | Systematic Assessment |
| |
| Fever - Grade 2 | General disorders | NCI-CTCAE | Systematic Assessment |
| |
| Flu like symptoms - Grade 2 | General disorders | NCI-CTCAE | Systematic Assessment |
| |
| Fracture - Grade 3 | Injury, poisoning and procedural complications | NCI-CTCAE | Systematic Assessment |
| |
| Gastroenteritis - Grade 3 | Gastrointestinal disorders | NCI-CTCAE | Systematic Assessment |
| |
| Clinical deterioration - Grade 5 | General disorders | NCI-CTCAE | Systematic Assessment |
| |
| Heart failure - Grade 3 | Cardiac disorders | NCI-CTCAE | Systematic Assessment |
| |
| Hematoma - Grade 2 | Blood and lymphatic system disorders | NCI-CTCAE | Systematic Assessment |
| |
| Hip fracture Grade 3 | Injury, poisoning and procedural complications | NCI-CTCAE | Systematic Assessment |
| |
| Hypotension - Grade 3 | Cardiac disorders | NCI-CTCAE | Systematic Assessment |
| |
| Herpes zoster - Grade 3 | Infections and infestations | NCI-CTCAE | Systematic Assessment |
| |
| Candidiasis - Grade 3 | Infections and infestations | NCI-CTCAE | Systematic Assessment |
| |
| Patient took expired medication - GradeUK | Injury, poisoning and procedural complications | NCI-CTCAE | Systematic Assessment |
| |
| Lung infection - Grade 3 | Infections and infestations | NCI-CTCAE | Systematic Assessment |
| |
| Lung infection - Grade 5 | Infections and infestations | NCI-CTCAE | Systematic Assessment |
| |
| Malaise - Grade 5 | General disorders | NCI-CTCAE | Systematic Assessment |
| |
| Renal tumor - Grade 4 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTCAE | Systematic Assessment |
| |
| Pain - Grade 3 | General disorders | NCI-CTCAE | Systematic Assessment |
| |
| Pericardial tamponade - Grade 3 | Cardiac disorders | NCI-CTCAE | Systematic Assessment |
| |
| Pericarditis - Grade 3 | Cardiac disorders | NCI-CTCAE | Systematic Assessment |
| |
| Pleural effusion - Grade 3 | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE | Systematic Assessment |
| |
| Respiratory failure - Grade 3 | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE | Systematic Assessment |
| |
| Respiratory failure - Grade 5 | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE | Systematic Assessment |
| |
| Partial respiratory failure-Grade 3 | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE | Systematic Assessment |
| |
| Sepsis - Grade 3 | Infections and infestations | NCI-CTCAE | Systematic Assessment |
| |
| Septic shock - Grade 5 | Infections and infestations | NCI-CTCAE | Systematic Assessment |
| |
| Transient ischemic attacks - Grade 2 | Nervous system disorders | NCI-CTCAE | Systematic Assessment |
| |
| Tumor lysis syndrome - Grade 4 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTCAE | Systematic Assessment |
| |
| Upper respiratory infection - Grade 3 | Infections and infestations | NCI-CTCAE | Systematic Assessment |
| |
| Upper respiratory infection - Grade 5 | Infections and infestations | NCI-CTCAE | Systematic Assessment |
| |
| Urinary tract infection - Grade 3 | Infections and infestations | NCI-CTCAE | Systematic Assessment |
| |
| Urinary tract infection - Grade 4 | Infections and infestations | NCI-CTCAE | Systematic Assessment |
| |
| Subarachnoid hemorrhage - Grade 2 | Vascular disorders | NCI-CTCAE | Systematic Assessment |
| |
| Vomiting - Grade 2 | Gastrointestinal disorders | NCI-CTCAE | Systematic Assessment |
| |
| Vomiting - Grade 3 | Gastrointestinal disorders | NCI-CTCAE | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet count decreased | Blood and lymphatic system disorders | NCI-CTCAE | Systematic Assessment |
| |
| Neutrophil count decreased | Blood and lymphatic system disorders | NCI-CTCAE | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | NCI-CTCAE | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | NCI-CTCAE | Systematic Assessment |
| |
| Nausea | General disorders | NCI-CTCAE | Systematic Assessment |
| |
| Lymphocyte count decrease | Blood and lymphatic system disorders | NCI-CTCAE | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI-CTCAE | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | NCI-CTCAE | Systematic Assessment |
| |
| Fatigue | General disorders | NCI-CTCAE | Systematic Assessment |
| |
| Hypomagnesemia | Blood and lymphatic system disorders | NCI-CTCAE | Systematic Assessment |
|
The main limitation of the IBDCL trial was the lack of randomization and a parallel control group, that precluded comparison of outcome measures with other existing therapeutic approaches.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Responsable person designated by the sponsor | MFAR | +34934344412 | investigacion@mfar.net |
| May 17, 2024 |
| Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2021 | Jan 27, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| 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
Not provided
| ID | Term |
|---|---|
| C551803 | ibrutinib |
| D000069283 | Rituximab |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| 1 |
|
| 2 |
|
| DLBCL rich in T lymphocytes |
|
| Follicular lymphoma |
|
| 2-3 |
|
| 4-5 |
|
| Unk |
|
| II |
|
| III |
|
| IV |
|
| Unk |
|
| Elevated |
|
| Unk |
|
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