| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012476-28; CLL11 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| German CLL Study Group | OTHER |
| Genentech, Inc. | INDUSTRY |
This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.
Protocol BO21004 is divided into 3 separate Unique Protocol IDs for reporting results on clinicaltrials.gov because there are 3 separate primary analyses conducted at different time-points.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obinutuzumab + chlorambucil (GClb) | Experimental | Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). |
|
| rituximab + chlorambucil (RClb) | Active Comparator | Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles). |
|
| Chlorambucil (Clb) | Active Comparator | Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| obinutuzumab | Drug | 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease (PD) required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L). | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| Percentage of Participants With Progression Free Survival Events | Percentage of Participants with Progression Free Survival Events: disease progression, relapse, or death. | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival Based on Independent Review Committee (IRC) Data | PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | 92123 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38620092 | Derived | Langerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564. | |
| 33131249 |
Not provided
Not provided
589 patients were randomized to 1 of 3 treatment groups in 2:2:1 ratio: GClb (n=238), RClb (n=233) or Clb (n=118) in Stage 1 and an additional 192 randomized to GClb or RClb in Stage 2 [NCT02053610]. Stage 1 was divided for analysis into: Stage 1a (GClb vs Clb) n=356 reported here and Stage 1b (RClb vs Clb) [NCT01998880] reported separately.
787 patients were enrolled in the study. Following a 6 patient safety run-in prior to randomization, 781 patients were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Obinutuzumab + Chlorambucil (GClb) | Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| rituximab | Drug | 375 mg/m^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6. |
|
|
| chlorambucil | Drug | Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle. |
|
| Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months) |
| Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data | Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee. | Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months) |
| Percentage of Participants With End of Treatment Response (EOTR) | EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase. | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| Percentage of Participants With Best Overall Response | Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase. | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| Event Free Survival | Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L). | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| Overall Survival | Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause. | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| Duration of Response | Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines. | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| Percentage of Participants With Molecular Remission at the End of Treatment | Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR). | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| Time to Re-Treatment/New-antileukemic Therapy | Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy. | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb) | Blood samples were collected from all patients allocated to the GClb treatment arm pre- and post-dose Day 1 of Cycles 1 to 6 and were sent to a laboratory. The concentration of obinutzumab in serum was determined using a validated enzyme-linked immunosorbent assay (ELISA) and was reported in micrograms/milliliter (μg/mL). | Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months) |
| European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score | The EORTC Quality of Life Questionnaire QLQ-C30 was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement. | Baseline and Cycle 4 Day 1 (Cy4D1) |
| European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score | EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement. | Baseline and Cycle 4 Day 1 (Cy4D1) |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Baltimore | Maryland | 21215 | United States |
| Green Bay | Wisconsin | 54311 | United States |
| Waukesha | Wisconsin | 53188 | United States |
| Buenos Aires | 1406 | Argentina |
| Buenos Aires | 1425 | Argentina |
| Buenos Aires | C1114AAN | Argentina |
| Buenos Aires | C1180AAX | Argentina |
| Buenos Aires | C1221ADC | Argentina |
| Buenos Aires | C1431FWO | Argentina |
| Rosario | 2000 | Argentina |
| Adelaide | New South Wales | 5011 | Australia |
| Gosford | New South Wales | 2250 | Australia |
| Kogarah | New South Wales | 2217 | Australia |
| Liverpool | New South Wales | 2170 | Australia |
| St Leonards | New South Wales | 2065 | Australia |
| Sydney | New South Wales | 2139 | Australia |
| Greenslopes | Queensland | 4120 | Australia |
| Southport | Queensland | 4215 | Australia |
| Woolloongabba | Queensland | 4102 | Australia |
| Kurralta Park | South Australia | 5037 | Australia |
| Frankston | Victoria | 3199 | Australia |
| Melbourne | Victoria | 3168 | Australia |
| Graz | 8036 | Austria |
| Innsbruck | 6020 | Austria |
| Vienna | 1090 | Austria |
| Vienna | 1160 | Austria |
| Goiânia | Goiás | 74140-050 | Brazil |
| Belo Horizonte | Minas Gerais | 31270-901 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90880-480 | Brazil |
| Santo André | São Paulo | 09060-650 | Brazil |
| São Paulo | São Paulo | 05403-000 | Brazil |
| Pleven | 5800 | Bulgaria |
| Plovdiv | 4002 | Bulgaria |
| Sofia | 1756 | Bulgaria |
| Varna | 9010 | Bulgaria |
| Vratsa | 3000 | Bulgaria |
| Calgary | Alberta | T2N 4N2 | Canada |
| Edmonton | Alberta | T6G 1Z2 | Canada |
| Winnipeg | Manitoba | R0C 2Z0 | Canada |
| Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Barrie | Ontario | L4M 6M2 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Montreal | Quebec | H2L 4M1 | Canada |
| Rimouski | Quebec | G5L 5T1 | Canada |
| Zagreb | 10000 | Croatia |
| Brno | 625 00 | Czechia |
| Hradec Králové | 500 05 | Czechia |
| Prague | 128 08 | Czechia |
| Aalborg | 9000 | Denmark |
| Aarhus | 8000 | Denmark |
| Copenhagen | 2100 | Denmark |
| Odense | 5000 | Denmark |
| Vejle | 7100 | Denmark |
| Cairo | 11796 | Egypt |
| Tallinn | 13419 | Estonia |
| Tartu | 51014 | Estonia |
| Angers | 49933 | France |
| Bobigny | 93009 | France |
| Caen | 14076 | France |
| Clermont-Ferrand | 63003 | France |
| Créteil | 94010 | France |
| Le Mans | 72015 | France |
| Lille | 59037 | France |
| Lyon | 69373 | France |
| Marseille | 13273 | France |
| Montpellier | 34295 | France |
| Nantes | 44093 | France |
| Paris | 75475 | France |
| Paris | 75651 | France |
| Pessac | 33604 | France |
| Pierre-Bénite | 69495 | France |
| Poitiers | 86021 | France |
| Reims | 51092 | France |
| Rennes | 35033 | France |
| Rouen | 76038 | France |
| Toulouse | 31059 | France |
| Tours | 37044 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Ahaus | 48683 | Germany |
| Amberg | 92224 | Germany |
| Ansbach | 91522 | Germany |
| Bamberg | 96049 | Germany |
| Berlin | 12200 | Germany |
| Bonn | 53113 | Germany |
| Bremen | 28177 | Germany |
| Bremen | 28209 | Germany |
| Bremen | 28239 | Germany |
| Cologne | 50674 | Germany |
| Cologne | 50924 | Germany |
| Delitzsch | 04509 | Germany |
| Detmold | 32756 | Germany |
| Dresden | 01127 | Germany |
| Dresden | 01307 | Germany |
| Duisburg | 47051 | Germany |
| Erlangen | 91052 | Germany |
| Erlangen | 91054 | Germany |
| Eschweiler | 52249 | Germany |
| Essen | 45122 | Germany |
| Essen | 45239 | Germany |
| Esslingen am Neckar | 73730 | Germany |
| Frankfurt | 60596 | Germany |
| Frankfurt (Oder) | 15236 | Germany |
| Frankfurt am Main | 60389 | Germany |
| Frechen | 50226 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Giessen | Germany |
| Göttingen | 37075 | Germany |
| Greifswald | 17475 | Germany |
| Hamburg | 20095 | Germany |
| Hamburg | 20099 | Germany |
| Hamburg | 20246 | Germany |
| Hamburg | 22081 | Germany |
| Hamburg | 22087 | Germany |
| Hamburg | 22767 | Germany |
| Hamm | 59063 | Germany |
| Hanover | 30449 | Germany |
| Heidelberg | 69120 | Germany |
| Homburg/Saar | 66241 | Germany |
| Kaiserslautern | 67655 | Germany |
| Karlsruhe | 76133 | Germany |
| Kempten | 87439 | Germany |
| Kiel | 24116 | Germany |
| Koblenz | 56068 | Germany |
| Kronach | 96317 | Germany |
| Landshut | 84028 | Germany |
| Lebach | 66822 | Germany |
| Leer | 26789 | Germany |
| Lemgo | 32657 | Germany |
| Loerrach | 79539 | Germany |
| Lüdenscheid | 58515 | Germany |
| Magedburg | 39104 | Germany |
| Mainz | 55131 | Germany |
| Mannheim | 68161 | Germany |
| Mutlangen | 73557 | Germany |
| München | 80335 | Germany |
| München | 81241 | Germany |
| München | 81377 | Germany |
| München | 81479 | Germany |
| München | 81675 | Germany |
| Neunkirchen/Saar | 66538 | Germany |
| Nuremberg | 90449 | Germany |
| Oldenburg | 26121 | Germany |
| Porta Westfalica | 32457 | Germany |
| Ravensburg | 88212 | Germany |
| Recklinghausen | 45657 | Germany |
| Regensburg | 93049 | Germany |
| Regensburg | 93053 | Germany |
| Rostock | 18057 | Germany |
| Rüsselsheim am Main | 65428 | Germany |
| Saarbrücken | 66113 | Germany |
| Sindelfingen | 71065 | Germany |
| Stuttgart | 70199 | Germany |
| Trier | 54290 | Germany |
| Tübingen | 72076 | Germany |
| Ulm | 89081 | Germany |
| Villingen-Schwenningen | 78052 | Germany |
| Weilheim | 82362 | Germany |
| Wendlingen | 73240 | Germany |
| Witten | 58452 | Germany |
| Worms | 67547 | Germany |
| Würzburg | 97080 | Germany |
| Hong Kong | Hong Kong |
| Cagliari | 09121 | Italy |
| Cosenza | 87100 | Italy |
| Ferrara | 44100 | Italy |
| Genova | 16132 | Italy |
| Messina | 98165 | Italy |
| Milan | 20132 | Italy |
| Milan | 20162 | Italy |
| Modena | 41100 | Italy |
| Orbassano | 10043 | Italy |
| Roma | 00144 | Italy |
| Roma | 00161 | Italy |
| Roma | 00168 | Italy |
| Terni | 05100 | Italy |
| Torino | 10126 | Italy |
| Aguascalientes | 20127 | Mexico |
| Culiacán | 80230 | Mexico |
| Hermosillo | 83000 | Mexico |
| Monterrey | 64460 | Mexico |
| San Luis Potosí City | 78218 | Mexico |
| Delftzijl | 9934 JD | Netherlands |
| Enschede | 7511 JX | Netherlands |
| Leeuwarden | 8934 AD | Netherlands |
| Nieuwegein | 3430 EM | Netherlands |
| Auckland | 1009 | New Zealand |
| Christchurch | 8011 | New Zealand |
| Bucharest | 022328 | Romania |
| Bucharest | 030171 | Romania |
| Târgu Mureş | 540136 | Romania |
| Kazan' | 420029 | Russia |
| Nizhny Novgorod | 603126 | Russia |
| Penza | 440071 | Russia |
| Perm | 614077 | Russia |
| Rostov-on-Don | 344022 | Russia |
| Ufa | 450005 | Russia |
| Bratislava | 833 10 | Slovakia |
| Manresa | Barcelona | 08240 | Spain |
| Sabadell | Barcelona | 08208 | Spain |
| Jerez de la Frontera | Cadiz | 11407 | Spain |
| Santander | Cantabria | 39008 | Spain |
| Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| A Coruña | LA Coruña | 15006 | Spain |
| Santiago de Compostela | LA Coruña | 15706 | Spain |
| Pamplona | Navarre | 31008 | Spain |
| Oviedo | Principality of Asturias | 33006 | Spain |
| San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Gandia | Valencia | 46702 | Spain |
| Barcelona | 08003 | Spain |
| Barcelona | 08025 | Spain |
| Barcelona | 08035 | Spain |
| Barcelona | 08036 | Spain |
| Jaén | 23007 | Spain |
| Las Palmas | 35020 | Spain |
| Madrid | 28006 | Spain |
| Madrid | 28031 | Spain |
| Madrid | 28033 | Spain |
| Madrid | 28034 | Spain |
| Madrid | 28041 | Spain |
| Madrid | 28046 | Spain |
| Madrid | 28222 | Spain |
| Madrid | 28905 | Spain |
| Málaga | 29010 | Spain |
| Málaga | 29600 | Spain |
| Murcia | 30008 | Spain |
| Murcia | 30120 | Spain |
| Salamanca | 37007 | Spain |
| Seville | 41014 | Spain |
| Toledo | 45004 | Spain |
| Toledo | 45600 | Spain |
| Valencia | 46009 | Spain |
| Valencia | 46010 | Spain |
| Valencia | 46014 | Spain |
| Valencia | 46015 | Spain |
| Valencia | 46017 | Spain |
| Zaragoza | 50009 | Spain |
| Aarau | 5001 | Switzerland |
| Basel | 4031 | Switzerland |
| Bern | 3010 | Switzerland |
| Chur | 7000 | Switzerland |
| Lucerne | 6000 | Switzerland |
| Sankt Gallen | 9007 | Switzerland |
| Zurich | 8091 | Switzerland |
| Bangkok | 10330 | Thailand |
| Bangkok | 10400 | Thailand |
| Bangkok | 10700 | Thailand |
| Khon Kaen | 40002 | Thailand |
| Bournemouth | BH7 7DW | United Kingdom |
| Cambridge | CB2 0QQ | United Kingdom |
| Canterbury | CT1 3NG | United Kingdom |
| Cardiff | CF14 4XN | United Kingdom |
| Cottingham | HU16 5JG | United Kingdom |
| Edinburgh | EH4 2XU | United Kingdom |
| Glasgow | G12 0YN | United Kingdom |
| Leicester | LE1 5WW | United Kingdom |
| London | EC1M 6BQ | United Kingdom |
| London | NW3 2QG | United Kingdom |
| Nottingham | NG5 1PB | United Kingdom |
| Sutton | SM2 5PT | United Kingdom |
| Derived |
| Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Dohner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027. |
| 31050355 | Derived | Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12. |
| 24401022 | Derived | Goede V, Fischer K, Busch R, Engelke A, Eichhorst B, Wendtner CM, Chagorova T, de la Serna J, Dilhuydy MS, Illmer T, Opat S, Owen CJ, Samoylova O, Kreuzer KA, Stilgenbauer S, Dohner H, Langerak AW, Ritgen M, Kneba M, Asikanius E, Humphrey K, Wenger M, Hallek M. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014 Mar 20;370(12):1101-10. doi: 10.1056/NEJMoa1313984. Epub 2014 Jan 8. |
| FG001 |
| Chlorambucil (Clb) |
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil. |
| Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline measures are based on the participants who were included in the Stage 1a analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Obinutuzumab + Chlorambucil (GClb) | Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). |
| BG001 | Chlorambucil (Clb) | Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil. |
| 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, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | 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 | Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease (PD) required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L). | Intent-to-treat population included all randomized participants. Patients without PFS events were censored. | Posted | Median | 95% Confidence Interval | Months | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Progression Free Survival Events | Percentage of Participants with Progression Free Survival Events: disease progression, relapse, or death. | Intent-to-treat population included all randomized participants. | Posted | Number | Percentage of participants | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival Based on Independent Review Committee (IRC) Data | PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L). | Intent-to-treat population included all randomized participants. Patients without PFS events were censored. | Posted | Median | 95% Confidence Interval | Months | Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data | Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee. | Intent-to-treat population included all randomized participants. Participants without PFS events were censored. | Posted | Number | Percentage of participants | Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With End of Treatment Response (EOTR) | EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase. | Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded. | Posted | Number | 95% Confidence Interval | Percentage of participants | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Best Overall Response | Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase. | Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded. | Posted | Number | 95% Confidence Interval | Percentage of participants | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event Free Survival | Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L). | Intent-to-treat population included all randomized participants. Patients without EFS events were censored. | Posted | Median | 95% Confidence Interval | Months | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause. | Intent-to-treat population included all randomized participants. Patients without OS events were censored. | Posted | Median | 95% Confidence Interval | Months | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines. | Participants from the Intent-to-treat population (all randomized participants) with CR or PR. Participants without response were censored. | Posted | Median | 95% Confidence Interval | Months | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Molecular Remission at the End of Treatment | Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR). | Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded. | Posted | Number | 95% Confidence Interval | Percentage of participants | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Re-Treatment/New-antileukemic Therapy | Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy. | Intent-to-treat population included all randomized participants. Participants without events (re-treatment or new anti-leukemic therapy) were censored. | Posted | Median | 95% Confidence Interval | Months | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb) | Blood samples were collected from all patients allocated to the GClb treatment arm pre- and post-dose Day 1 of Cycles 1 to 6 and were sent to a laboratory. The concentration of obinutzumab in serum was determined using a validated enzyme-linked immunosorbent assay (ELISA) and was reported in micrograms/milliliter (μg/mL). | PK population includes all participants with PK data available at the given time-point. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score | The EORTC Quality of Life Questionnaire QLQ-C30 was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement. | ITT population. Here, n signifies the number of participants who were evaluated for specified categories. | Posted | Mean | Standard Deviation | unit on a scale | Baseline and Cycle 4 Day 1 (Cy4D1) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score | EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement. | ITT population. Here, n signifies the number of participants who were evaluated for specified categories. | Posted | Mean | Standard Deviation | unit on a scale | Baseline and Cycle 4 Day 1 (Cy4D1) |
|
Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
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 | Obinutuzumab + Chlorambucil (GClb) | Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). | 113 | 241 | 215 | 241 | ||
| EG001 | Chlorambucil (Clb) | Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil. | 45 | 116 | 89 | 116 | ||
| EG002 | Crossover Subjects: Obinutuzumab + Chlorambucil (GClb) | Subjects in Clb arm who progressed during/within 6 months after end of Clb treatment had opportunity to cross over to GClb arm at discretion of investigator. Subjects received 1000 mg obinutuzumab IV infusion, on Day 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 milligram per kilogram of body weight (mg/kg) orally on Day 1 and 15 of each 28-day cycle (6 Cycles). | 8 | 30 | 23 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Dacryocystitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Stenotrophomonas sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Superinfection bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Choroid melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Intraocular melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Schwannoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Superficial spreading melanoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nodal rhythm | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombosis mesenteric vessel | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Central nervous system haemorrhage | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diabetic macroangiopathy | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dry gangrene | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hereditary non-polyposis colorectal cancer syndrome | Congenital, familial and genetic disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Prostatic obstruction | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Testicular hypertrophy | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Fracture treatment | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
| |
| Radius Fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Basosquamous Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Skin Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Lung Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Major depression | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infections | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C543332 | obinutuzumab |
| D000069283 | Rituximab |
| D002699 | Chlorambucil |
| 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 |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Male |
|
|
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil. |
|
|
|
| Participants |
|
|
| OG001 | Chlorambucil (Clb) | Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil. |
|
|
| OG001 | Chlorambucil (Clb) | Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil. |
|
|
|
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil. |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil. |
|
|
| Participants |
|
|
|
|
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil. |
|
|
|
|