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The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20 (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients with CD20-positive diffuse large B-cell lymphoma.
Patients who meet criteria for participation in this study receive 8 intravenous infusions of MabionCD20® or MabThera® 21 days interval in combination with standard dosage regimen of CHOP. The duration of the study is 12 months. The treatment and observation period will last 26 weeks starting from Day 1, until Week 26 - one month after last IMP infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MabionCD20 | Experimental | A course of MabionCD20 consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles. Intervention: Drug: Rituximab |
|
| MabThera | Active Comparator | A course of MabThera consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles. Intervention: Drug: Rituximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | 375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4]) | Area under the serum concentration-time curve from time zero (Day 1) to final time point measured after the first administration (Week 1) until Week 4 (AUC(W1-W4)). PK blood samples for this endpoint were drawn at Day 1 (before and after the first infusion), Day 8 ± 1 (7 days after first infusion), Day 15 ± 1 (14 days after first infusion), Day 22 ± 2 (before and after completion of the second infusion). | Baseline to Week 4 |
| Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26]) | Area under the serum concentration-time curve from time zero to final time point measured from Week 13 until Week 26 (AUC[W13-W26]). PK blood samples for this endpoint were drawn at Day 85 ± 4 (before and after completion of the fifth infusion), Day 106 ± 4 (before and after completion of sixth infusion), Day 127 ± 4 (before and after completion of the seventh infusion), Day 148 ± 4 (before and after completion of the eight infusion), Day 155 ± 4 (one week after last infusion) and Day 176 ± 4 (one month after last infusion). | Week 13 to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Ctrough (Before 8th Infusion) | Trough serum concentration measured at the end of a dosing interval at steady state, taken directly before eighth infusion. | Week 22 |
| Cmax (Post 5th and 8th Infusion) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Percentage of patients with positive ADA or NAb results in a given category. Data pertain to the entire follow-up period (from Baseline to Week 46). | from baseline to Week 46 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Center Banja Luka | Banja Luka | 78 000 | Bosnia and Herzegovina | |||
| University Clinical Center Sarajevo |
Screening lasted 28 days (from Day -35 to -8 before randomization), during which the eligibility status of patients was verified.
Forty-eight patients were excluded before randomization: 45 patients did not meet eligibility criteria, one patient declined participation and two patients could not be randomized because of the limited availability of investigational drugs.
The trial was initiated in 7 countries (Croatia, Bosnia and Herzegovina, Georgia, Moldova, Poland, Serbia, and Ukraine), but finally only 5 countries with 21 study sites recruited patients (Bosnia and Herzegovina, Georgia, Moldova, Poland, and Ukraine).
Start date of recruitment: 29.03.2016
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| ID | Title | Description |
|---|---|---|
| FG000 | MabionCD20 | Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22). Patients randomly assigned to MabionCD20 were followed up until Week 46. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment and Observation Period |
|
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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 21, 2016 | Apr 8, 2022 |
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| Doxorubicin | Drug | 50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle |
|
|
| Vincristine | Drug | 1.4 mg of vincristine per square meter, up to a maximal dose of 2 mg, administrated IV on day 1 of each chemotherapy cycle |
|
|
| Cyclophosphamide | Drug | 750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle |
|
| prednisone | Drug | 100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle |
|
Maximum serum drug concentration (Cmax) at steady state after the 5th and 8th infusions.
| Week 13 (5th infusion) and Week 22 (8th infusion) |
| Kel (Post 5th and 8th Infusions) | Elimination Rate Constant at steady stade after the 5th and 8th infusions. | Week 13 (5th infusion) and Week 22 (8th infusion) |
| T1/2 (Post 5th and 8th Infusions) | Elimination half-life at steady state after the 5th and 8th infusions. | Week 13 to Week 16 and Week 22 to Week 26 |
| CLss (Post 5th and 8th Infusions) | Clearance at steady state after the 5th and 8th infusions. | Week 13 to Week 16 and Week 22 to Week 26 |
| AUC (W1-W26) B-cell | Area under the serum concentration-time curve of CD19+ B cell counts, measured from the first administration to the final time point at Week 26 (AUC(1-26) B-cell). | baseline to Week 26 |
| AUC (W1-W26) | Area under the serum concentration-time curve measured after the first administration (Week 1) until Week 26 (AUC(1-26)) | Week 1 until Week 26 |
| Efficacy Assessment at Week 26 | An efficacy assessment was made after 8 treatment cycles (at Week 26) based on tumour responses classified according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (Cheson et al. 1999). Response was assessed based on clinical, radiologic (CT scan) and pathologic (bone marrow) criteria. Possible efficacy responses were: complete response, partial response, stable disease, and progressive disease. Efficacy reported here includes all patients included in the ITT set. | Week 26 |
| Adverse Events | Percentage of patients with at least one AE in a given category. Data from the entire follow-up are included (Period 1 and Period 2). | from baseline to Week 46 |
| Sarajevo |
| 71 000 |
| Bosnia and Herzegovina |
| University Clinical Center Tuzla | Tuzla | 75 000 | Bosnia and Herzegovina |
| General Hospital Zenica | Zenica | 72 000 | Bosnia and Herzegovina |
| GH "dr.Josip Bencevic" | Slavonski Brod | 35000 | Croatia |
| CH Merkur | Zagreb | 10000 | Croatia |
| CHC Zagreb | Zagreb | 10000 | Croatia |
| HEMA | Tbilisi | 0112 | Georgia |
| S. Khechinashvili state University clinic | Tbilisi | 0179 | Georgia |
| Medulla - Chemotherapy and Immunotherapy Clinic | Tbilisi | 0186 | Georgia |
| Institut of Oncology, Hematology Department | Chisinau | 2025 | Moldova |
| Wojewódzki Szpital Specjalistyczny w Legnicy, Oddział Hematologiczny | Legnica | 59-220 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr1, Klinika Hematologii i Transplantacji Szpiku | Lublin | 20-081 | Poland |
| Szpital Wojewódzki w Opolu, Oddział Hematologii i Onkologii Hematologicznej | Opole | 45-061 | Poland |
| MTZ Clinical Research Sp. Z o.o. | Warsaw | 02-106 | Poland |
| Clinical Hospital Center Zemun | Belgrade | 11000 | Serbia |
| Clinical Hospital Center Zvezdara | Belgrade | 11000 | Serbia |
| Military Hospital Academy | Belgrade | 11000 | Serbia |
| Public utility "Chernivtsi regional clinical oncology dispensary", Day patient department | Chernivtsi | 58013 | Ukraine |
| Municipal Institution "Dnipropetrovsk City multi-field Clinical Hospital #4", Oncology and medical radiology department | Dnipropetrovsk | 49102 | Ukraine |
| Regional Clinical Hospital of Ivano-Frankivsk, Hematology Department. | Ivano-Frankivsk | 76008 | Ukraine |
| Regional Clinical Oncology Dispensary, Chemotherapy Department | Ivano-Frankivsk | 76018 | Ukraine |
| Kharkiv Regional Clinical Oncology Centre, Deartment of haematology | Kharkiv | 61070 | Ukraine |
| National Institute of Cancer, Department of chemotherapy | Kiev | 03022 | Ukraine |
| Kiev City Clinical Oncological Center, Department of chemotherapy #2 | Kiev | 03115 | Ukraine |
| Utility Enterprise "Kirovograd regional oncology dispensary" | Kirovohrad | 25011 | Ukraine |
| Kryvyi Rih Oncology Dispensary, Dnipropetrovsk Highway | Kryvyi Rih | 50048 | Ukraine |
| Volyn' Regional clinical hospital, Haematology Department | Lutsk | 45634 | Ukraine |
| State institution "Institute for haemotopathology and haemotransfusion of National Academy of science of Ukraine | Lviv | 79044 | Ukraine |
| Mykolayiv Region Clinical Hospital, Heamotology department | Mykolayiv | 54058 | Ukraine |
| Poltava regional oncology hospital, heamotherapy department | Poltava | 36011 | Ukraine |
| Regional clinical Hospital named after Novak, Hematology Department | Uzhhorod | 88000 | Ukraine |
| Vinnitsya Regional Clinical Oncology Dispensary, Chemotherapy Department, | Vinnitsya | 21029 | Ukraine |
| Regional Oncology dispensary | Zaporizhzhia | 69040 | Ukraine |
| Zaporizhzhya Regional Clinical Hospital, Deartment of haematology and intensive therapy | Zaporizhzhia | 69600 | Ukraine |
| MabThera |
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22). Patients randomly assigned to MabThera were followed up until Week 46. |
| COMPLETED |
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| NOT COMPLETED |
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|
| Follow-up Period |
|
|
SAF (all patients randomized into the study and receiving at least one infusion of MabionCD20 or MabThera).
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| ID | Title | Description |
|---|---|---|
| BG000 | MabionCD20 | Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22). |
| BG001 | MabThera | Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22). |
| BG002 | 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 |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| BSA | Mean | Standard Deviation | cubic metre |
| |||||||||||||||||
| Body weight | Mean | Standard Deviation | kilograms |
|
| 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 | Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4]) | Area under the serum concentration-time curve from time zero (Day 1) to final time point measured after the first administration (Week 1) until Week 4 (AUC(W1-W4)). PK blood samples for this endpoint were drawn at Day 1 (before and after the first infusion), Day 8 ± 1 (7 days after first infusion), Day 15 ± 1 (14 days after first infusion), Day 22 ± 2 (before and after completion of the second infusion). | PP W1-4 set (subset of ITT population based on patients without major protocol deviations to Week 4 (visit 4) and having a PK assessment on this visit. Completion of the study was not necessary for inclusion into this population). | Posted | Mean | Standard Deviation | (μg*day)/mL | Baseline to Week 4 |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26]) | Area under the serum concentration-time curve from time zero to final time point measured from Week 13 until Week 26 (AUC[W13-W26]). PK blood samples for this endpoint were drawn at Day 85 ± 4 (before and after completion of the fifth infusion), Day 106 ± 4 (before and after completion of sixth infusion), Day 127 ± 4 (before and after completion of the seventh infusion), Day 148 ± 4 (before and after completion of the eight infusion), Day 155 ± 4 (one week after last infusion) and Day 176 ± 4 (one month after last infusion). | PP W13-26 set (subset of ITT population based on patients without major protocol deviations and having a PK assessment from Week 13 to Week 26). | Posted | Mean | Standard Deviation | (μg*day)/mL | Week 13 to Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ctrough (Before 8th Infusion) | Trough serum concentration measured at the end of a dosing interval at steady state, taken directly before eighth infusion. | PP W13-26 set (subset of ITT population based on patients without major protocol deviations and having a PK assessment from Week 13 to Week 26). | Posted | Mean | Standard Deviation | μg/mL | Week 22 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmax (Post 5th and 8th Infusion) | Maximum serum drug concentration (Cmax) at steady state after the 5th and 8th infusions. | PP W13-26 set (subset of ITT population based on patients without major protocol deviations and having a PK assessment from Week 13 to Week 26). | Posted | Mean | Standard Deviation | μg/mL | Week 13 (5th infusion) and Week 22 (8th infusion) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kel (Post 5th and 8th Infusions) | Elimination Rate Constant at steady stade after the 5th and 8th infusions. | PP W13-26 set (subset of ITT population based on patients without major protocol deviations and having a PK assessment from Week 13 to Week 26). | Posted | Mean | Standard Deviation | 1/day | Week 13 (5th infusion) and Week 22 (8th infusion) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | T1/2 (Post 5th and 8th Infusions) | Elimination half-life at steady state after the 5th and 8th infusions. | PP W13-26 set (subset of ITT population based on patients without major protocol deviations and having a PK assessment from Week 13 to Week 26). | Posted | Mean | Standard Deviation | days | Week 13 to Week 16 and Week 22 to Week 26 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CLss (Post 5th and 8th Infusions) | Clearance at steady state after the 5th and 8th infusions. | PP W13-26 set (subset of ITT population based on patients without major protocol deviations and having a PK assessment from Week 13 to Week 26). | Posted | Mean | Standard Deviation | mL/day | Week 13 to Week 16 and Week 22 to Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC (W1-W26) B-cell | Area under the serum concentration-time curve of CD19+ B cell counts, measured from the first administration to the final time point at Week 26 (AUC(1-26) B-cell). | ITT set (a subset of safety population based on patients who had at least one complete post baseline assessment of the area under the serum concentration-time curve from time zero to final time point (AUC(0-t)), measured after the first administration (Week 1) until the second administration at Week 4(AUC(1-4)). | Posted | Mean | Standard Deviation | cells*days/mL blood | baseline to Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC (W1-W26) | Area under the serum concentration-time curve measured after the first administration (Week 1) until Week 26 (AUC(1-26)) | PP W1-W26 set | Posted | Mean | Standard Deviation | (μg*day)/mL | Week 1 until Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Efficacy Assessment at Week 26 | An efficacy assessment was made after 8 treatment cycles (at Week 26) based on tumour responses classified according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (Cheson et al. 1999). Response was assessed based on clinical, radiologic (CT scan) and pathologic (bone marrow) criteria. Possible efficacy responses were: complete response, partial response, stable disease, and progressive disease. Efficacy reported here includes all patients included in the ITT set. | ITT population including all randomized patients | Posted | Count of Participants | Participants | Week 26 |
|
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| Secondary | Adverse Events | Percentage of patients with at least one AE in a given category. Data from the entire follow-up are included (Period 1 and Period 2). | SAF set (all patients randomized into the study and receiving at least one infusion of MabionCD20 or MabThera). | Posted | Number | percent | from baseline to Week 46 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Immunogenicity | Percentage of patients with positive ADA or NAb results in a given category. Data pertain to the entire follow-up period (from Baseline to Week 46). | SAF set (sample from one patient not collected) | Posted | Number | participants | from baseline to Week 46 |
|
|
46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
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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 | MabionCD20 | Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22). | 8 | 100 | 19 | 100 | 70 | 100 |
| EG001 | MabThera | Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22). | 0 | 40 | 5 | 40 | 26 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pancreatic necrosis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Aspartate aminitransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| White blood count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Tuszyner | Mabion S.A. | +48504441105 | a.tuszyner@mabion.eu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2017 | Apr 8, 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 |
|---|---|
| D000069283 | Rituximab |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D003520 | Cyclophosphamide |
| D011241 | Prednisone |
| 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 |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| Disease progression |
|
| Need for CNS prophylaxis |
|
| Patient needed radiotherapy |
|
| Patient needed bone marrow transplantation |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
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| Participants |
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