CLL11: A Study of RO5072759 (GA101) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Collaborators:
German CLL Study Group
Genentech
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01010061
First received: November 6, 2009
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
This open-label, randomized, 3-arm study will evaluate the efficacy and safety of RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia. Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375mg/m2 cycle 1, 500mg/m2 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphocytic Leukemia, Chronic |
Drug: RO5072759 Drug: rituximab Drug: chlorambucil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: assessed every 2 weeks on study treatment, 28 days after last dose and at intervals for at least 5 years of follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate (ORR/CR/PR), duration of response and disease-free survival in CR-patients, overall survival [ Time Frame: assessed every 2 weeks on study treatment, 28 days after last dose and at intervals for at least 5 years of follow-up ] [ Designated as safety issue: No ]
- Molecular remission: minimal residual disease (MRD) [ Time Frame: assessed after 3 cycles and 1,3,6 and 12 months after end of treatment ] [ Designated as safety issue: No ]
- Safety profile: AEs, laboratory parameters [ Time Frame: monitored throughout study, laboratory assessments every 2 weeks on study treatment, 28 days after last dose and at intervals during follow-up ] [ Designated as safety issue: No ]
- Pharmacokinetics of RO5072759 in combination with Clb [ Time Frame: pre- and post-dose sampling on day 1 of cycles 1-6 ] [ Designated as safety issue: No ]
- Patient-reported outcomes and symptom burden by EORTC questionnaire [ Time Frame: after 3 cycles, 28 days after last dose and at intervals during follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 787 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | May 2021 |
| Estimated Primary Completion Date: | May 2021 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A (GClb) |
Drug: RO5072759
1000 mg by iv infusion, on days 1, 8 and 15 in cycle 1, day 1 in cycles 2-6 (28-day cycles)
Drug: chlorambucil
0,5 mg/kg orally on day 1 and 15 of each 28-day cycle
|
| Active Comparator: B (RClb) |
Drug: rituximab
by iv infusion on day 1 of each 28-day cycle, 375 mg/m2 cycle 1, 500 mg/m2 cycles 2-6
Drug: chlorambucil
0,5 mg/kg orally on day 1 and 15 of each 28-day cycle
|
| Active Comparator: C (Clb) |
Drug: chlorambucil
0,5 mg/kg orally on day 1 and 15 of each 28-day cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults >/=18 years
- Documented CD20+B-CLL
- Previously untreated CLL requiring treatment according to the NCI criteria
- Total CIRS > 6 and/or creatinine clearance < 70 ml/min
Exclusion Criteria:
- Prior CLL therapy
- Transformation of CLL to aggressive NHL (Richter's transformation)
- History of other malignancy unless the malignancy has been in remission without treatment for >/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or DCIS of the breast treated with lymphectomy alone
- Positive hepatitis serology (HBV, HCV) or positive HIV or HTLV testing
- Patients with active infection requiring systemic treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010061
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| United States, California | |
| San Diego, California, United States, 92123 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Wisconsin | |
| Green Bay, Wisconsin, United States, 54311 | |
| Waukesha, Wisconsin, United States, 53188 | |
| Argentina | |
| Buenos Aires, Argentina, 1406 | |
| Buenos Aires, Argentina, C1114AAN | |
| Buenos Aires, Argentina, C1180AAX | |
| Buenos Aires, Argentina, C1431FWO | |
| Buenos Aires, Argentina, 1425 | |
| Buenos Aires, Argentina, C1221ADC | |
| Rosario, Argentina, 2000 | |
| Australia, New South Wales | |
| Adelaide, New South Wales, Australia, 5011 | |
| Gosford, New South Wales, Australia, 2250 | |
| Kogarah, New South Wales, Australia, 2217 | |
| Liverpool, New South Wales, Australia, 2170 | |
| St. Leonards, New South Wales, Australia, 2065 | |
| Sydney, New South Wales, Australia, 2139 | |
| Australia, Queensland | |
| Greenslopes, Queensland, Australia, 4120 | |
| Southport, Queensland, Australia, 4215 | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Australia, South Australia | |
| Kurralta Park, South Australia, Australia, 5037 | |
| Australia, Victoria | |
| Frankston, Victoria, Australia, 3199 | |
| Melbourne, Victoria, Australia, 3168 | |
| Austria | |
| Graz, Austria, 8036 | |
| Innsbruck, Austria, 6020 | |
| Wien, Austria, 1090 | |
| Wien, Austria, 1160 | |
| Brazil | |
| Goiania, GO, Brazil, 74140-050 | |
| Belo Horizonte, MG, Brazil, 31270-901 | |
| Porto Alegre, RS, Brazil, 90880-480 | |
| Santo Andre, SP, Brazil, 09060-650 | |
| Sao Paulo, SP, Brazil, 05403-000 | |
| Bulgaria | |
| Pleven, Bulgaria, 5800 | |
| Plovdiv, Bulgaria, 4002 | |
| Sofia, Bulgaria, 1756 | |
| Varna, Bulgaria, 9010 | |
| Vratsa, Bulgaria, 3000 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R0C 2Z0 | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Canada, Ontario | |
| Barrie, Ontario, Canada, L4M 6M2 | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Rimouski, Quebec, Canada, G5L 5T1 | |
| Croatia | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| Brno, Czech Republic, 625 00 | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Praha 2, Czech Republic, 128 08 | |
| Denmark | |
| Aalborg, Denmark, 9000 | |
| København, Denmark, 2100 | |
| Odense, Denmark, 5000 | |
| Vejle, Denmark, 7100 | |
| Århus, Denmark, 8000 | |
| Egypt | |
| Cairo, Egypt, 11796 | |
| Estonia | |
| Tallinn, Estonia, 13419 | |
| Tartu, Estonia, 51014 | |
| France | |
| Angers, France, 49933 | |
| Bobigny, France, 93009 | |
| Caen, France, 14076 | |
| Clermont Ferrand, France, 63003 | |
| Creteil, France, 94010 | |
| Le Mans, France, 72015 | |
| Lille, France, 59037 | |
| Lyon, France, 69373 | |
| Marseille, France, 13273 | |
| Montpellier, France, 34295 | |
| Nantes, France, 44093 | |
| Paris, France, 75651 | |
| Paris, France, 75475 | |
| Pessac, France, 33604 | |
| Pierre Benite, France, 69495 | |
| Poitiers, France, 86021 | |
| Reims, France, 51092 | |
| Rennes, France, 35033 | |
| Rouen, France, 76038 | |
| Toulouse, France, 31059 | |
| Tours, France, 37044 | |
| Vandoeuvre Les Nancy, France, 54511 | |
| Germany | |
| Ahaus, Germany, 48683 | |
| Amberg, Germany, 92224 | |
| Ansbach, Germany, 91522 | |
| Bamberg, Germany, 96049 | |
| Berlin, Germany, 12200 | |
| Bonn, Germany, 53113 | |
| Bremen, Germany, 28177 | |
| Bremen, Germany, 28239 | |
| Bremen, Germany, 28209 | |
| Delitzsch, Germany, 04509 | |
| Detmold, Germany, 32756 | |
| Dresden, Germany, 01127 | |
| Dresden, Germany, 01307 | |
| Duisburg, Germany, 47051 | |
| Erlangen, Germany, 91052 | |
| Erlangen, Germany, 91054 | |
| Eschweiler, Germany, 52249 | |
| Essen, Germany, 45239 | |
| Essen, Germany, 45122 | |
| Esslingen, Germany, 73730 | |
| Frankfurt, Germany, 60596 | |
| Frankfurt am Main, Germany, 60389 | |
| Frankfurt an der Oder, Germany, 15236 | |
| Frechen, Germany, 50226 | |
| Freiburg, Germany, 79106 | |
| Giessen, Germany | |
| Greifswald, Germany, 17475 | |
| Göttingen, Germany, 37075 | |
| Hamburg, Germany, 22087 | |
| Hamburg, Germany, 20099 | |
| Hamburg, Germany, 22767 | |
| Hamburg, Germany, 20251 | |
| Hamburg, Germany, 20095 | |
| Hamburg, Germany, 22081 | |
| Hamm, Germany, 59063 | |
| Hannover, Germany, 30449 | |
| Heidelberg, Germany, 69120 | |
| Homburg/Saar, Germany, 66241 | |
| Kaiserslautern, Germany, 67655 | |
| Karlsruhe, Germany, 76133 | |
| Kempten, Germany, 87439 | |
| Kiel, Germany, 24116 | |
| Koblenz, Germany, 56068 | |
| Koeln, Germany, 50674 | |
| Kronach, Germany, 96317 | |
| Köln, Germany, 50924 | |
| Landshut, Germany, 84028 | |
| Lebach, Germany, 66822 | |
| Leer, Germany, 26789 | |
| Lemgo, Germany, 32657 | |
| Lörrach, Germany, 79539 | |
| Lüdenscheid, Germany, 58515 | |
| Magedburg, Germany, 39104 | |
| Mainz, Germany, 55131 | |
| Mannheim, Germany, 68161 | |
| Muenchen, Germany, 81377 | |
| Mutlangen, Germany, 73557 | |
| München, Germany, 81479 | |
| München, Germany, 80335 | |
| München, Germany, 81241 | |
| München, Germany, 81675 | |
| Neunkirchen/Saar, Germany, 66538 | |
| Nürnberg, Germany, 90449 | |
| Oldenburg, Germany, 26121 | |
| Porta Westfalica, Germany, 32457 | |
| Ravensburg, Germany, 88212 | |
| Recklinghausen, Germany, 45657 | |
| Regensburg, Germany, 93053 | |
| Regensburg, Germany, 93049 | |
| Rostock, Germany, 18057 | |
| Rüsselsheim, Germany, 65428 | |
| Saarbruecken, Germany, 66113 | |
| Sindelfingen, Germany, 71065 | |
| Stuttgart, Germany, 70199 | |
| Trier, Germany, 54290 | |
| Tübingen, Germany, 72076 | |
| Ulm, Germany, 89081 | |
| Villingen-Schwenningen, Germany, 78050 | |
| Weilheim, Germany, 82362 | |
| Wendlingen, Germany, 73240 | |
| Witten, Germany, 58452 | |
| Worms, Germany, 67547 | |
| Wuerzburg, Germany, 97080 | |
| Würzburg, Germany, 97070 | |
| Hong Kong | |
| Hong Kong, Hong Kong | |
| Italy | |
| Cagliari, Italy, 09121 | |
| Cosenza, Italy, 87100 | |
| Ferrara, Italy, 44100 | |
| Genova, Italy, 16132 | |
| Messina, Italy, 98165 | |
| Milano, Italy, 20162 | |
| Milano, Italy, 20132 | |
| Modena, Italy, 41100 | |
| Orbassano, Italy, 10043 | |
| Roma, Italy, 00161 | |
| Roma, Italy, 00168 | |
| Roma, Italy, 00144 | |
| Terni, Italy, 05100 | |
| Torino, Italy, 10126 | |
| Mexico | |
| Aguascalientes, Mexico, 20127 | |
| Culiacan, Mexico, 80230 | |
| Hermosillo, Mexico, 83000 | |
| Monterrey, Mexico, 64460 | |
| San Luis Potosi, Mexico, 78218 | |
| Netherlands | |
| Delftzijl, Netherlands, 9934 JD | |
| Enschede, Netherlands, 7511 JX | |
| Leeuwarden, Netherlands, 8934 AD | |
| Nieuwegein, Netherlands, 3430 EM | |
| New Zealand | |
| Auckland, New Zealand, 1009 | |
| Christchurch, New Zealand, 8011 | |
| Romania | |
| Bucharest, Romania, 022328 | |
| Bucuresti, Romania, 030171 | |
| Targu-mures, Romania, 540136 | |
| Russian Federation | |
| Kazan, Russian Federation, 420029 | |
| Nizhny Novgorod, Russian Federation, 603126 | |
| Penza, Russian Federation, 440071 | |
| Perm, Russian Federation, 614077 | |
| Rostov-na-donu, Russian Federation, 344022 | |
| UFA, Russian Federation, 450005 | |
| Slovakia | |
| Bratislava, Slovakia, 833 10 | |
| Spain | |
| Oviedo, Asturias, Spain, 33006 | |
| Manresa, Barcelona, Spain, 08240 | |
| Sabadell, Barcelona, Spain, 08208 | |
| Jerez de La Frontera, Cadiz, Spain, 11407 | |
| Santander, Cantabria, Spain, 39008 | |
| San Sebastian, Guipuzcoa, Spain, 20014 | |
| La Coruna, La Coruña, Spain, 15006 | |
| Santiago de Compostela, La Coruña, Spain, 15706 | |
| Pamplona, Navarra, Spain, 31008 | |
| La Laguna, Tenerife, Spain, 38320 | |
| Gandia, Valencia, Spain, 46702 | |
| Barcelona, Spain, 08025 | |
| Barcelona, Spain, 08003 | |
| Barcelona, Spain, 08036 | |
| Barcelona, Spain, 08035 | |
| Jaen, Spain, 23007 | |
| Las Palmas, Spain, 35020 | |
| Madrid, Spain, 28034 | |
| Madrid, Spain, 28905 | |
| Madrid, Spain, 28006 | |
| Madrid, Spain, 28033 | |
| Madrid, Spain, 28031 | |
| Madrid, Spain, 28046 | |
| Madrid, Spain, 28222 | |
| Madrid, Spain, 28041 | |
| Malaga, Spain, 29010 | |
| Malaga, Spain, 29600 | |
| Murcia, Spain, 30008 | |
| Murcia, Spain, 30120 | |
| Salamanca, Spain, 37007 | |
| Sevilla, Spain, 41014 | |
| Toledo, Spain, 45600 | |
| Toledo, Spain, 45004 | |
| Valencia, Spain, 46017 | |
| Valencia, Spain, 46009 | |
| Valencia, Spain, 46014 | |
| Valencia, Spain, 46010 | |
| Valencia, Spain, 46015 | |
| Zaragoza, Spain, 50009 | |
| Switzerland | |
| Aarau, Switzerland, 5001 | |
| Basel, Switzerland, 4031 | |
| Bern, Switzerland, 3010 | |
| Chur, Switzerland, 7000 | |
| Luzern, Switzerland, 6000 | |
| St. Gallen, Switzerland, 9007 | |
| Zürich, Switzerland, 8091 | |
| Thailand | |
| Bangkok, Thailand, 10400 | |
| Bangkok, Thailand, 10700 | |
| Bangkok, Thailand, 10330 | |
| Khon Kaen, Thailand, 40002 | |
| United Kingdom | |
| Bournemouth, United Kingdom, BH7 7DW | |
| Cambridge, United Kingdom, CB2 0QQ | |
| Canterbury, United Kingdom, CT1 3NG | |
| Cardiff, United Kingdom, CF14 4XN | |
| Cottingham, United Kingdom, HU16 5JG | |
| Edinburgh, United Kingdom, EH4 2XU | |
| Glasgow, United Kingdom, G12 0YN | |
| Leicester, United Kingdom, LE1 5WW | |
| London, United Kingdom, NW3 2QG | |
| London, United Kingdom, EC1M 6BQ | |
| Nottingham, United Kingdom, NG5 1PB | |
| Sutton, United Kingdom, SM2 5PT | |
Sponsors and Collaborators
Hoffmann-La Roche
German CLL Study Group
Genentech
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01010061 History of Changes |
| Other Study ID Numbers: | BO21004, 2009-012476-28; CLL1 |
| Study First Received: | November 6, 2009 |
| Last Updated: | June 3, 2013 |
| Health Authority: | Australia: National Health and Medical Research Coincil |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Chronic Disease Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Attributes |
Pathologic Processes Chlorambucil Rituximab Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 18, 2013