CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)

NCT01010061 | Completed Phase 3 Results

• 2 other identifiers: BO21004 (Stage 1a)2009-012476-28; CLL11
• Study Type: interventional
• Target: 787
• Locations: 24 countries
• Sites: 210

Brief Summary

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.

Conditions

Lymphocytic Leukemia, Chronic

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (12)

• Progression Free Survival Based on Independent Review Committee (IRC) Data

  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

  Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)

• Percentage of Participants With End of Treatment Response (EOTR)

  Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)

• Percentage of Participants With Best Overall Response

  Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)

• Event Free Survival

  Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)

Study Arms (3)

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).

Drug: obinutuzumab; Drug: chlorambucil

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).

Drug: rituximab; Drug: chlorambucil

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.

Drug: chlorambucil

Interventions

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).

Also known as: RO5072759, GA101, GAZYVA®

obinutuzumab + chlorambucil (GClb)

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.

Also known as: Rituxan®, MabThera®

rituximab + chlorambucil (RClb)

chlorambucil DRUG

Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle.

Chlorambucil (Clb); obinutuzumab + chlorambucil (GClb); rituximab + chlorambucil (RClb)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>/=18 years
• Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)
• Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria
• Total Cumulative Illness Rating Scale (CIRS) \> 6 and/or creatinine clearance \< 70 ml/min

You may not qualify if:

• Prior CLL therapy
• Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (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 ductal carcinoma in situ (DCIS) of the breast treated with lymphectomy alone
• Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus (HTLV) testing
• Patients with active infection requiring systemic treatment

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• German CLL Study Group: collaborator
• Genentech, Inc.: collaborator

Study Sites (261)

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San Diego, California, 92123, United States

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Chicago, Illinois, 60637, United States

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Baltimore, Maryland, 21215, United States

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Green Bay, Wisconsin, 54311, United States

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Waukesha, Wisconsin, 53188, United States

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Buenos Aires, 1406, Argentina

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Buenos Aires, 1425, Argentina

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Buenos Aires, C1114AAN, Argentina

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Buenos Aires, C1180AAX, Argentina

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Buenos Aires, C1221ADC, Argentina

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Buenos Aires, C1431FWO, Argentina

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Rosario, 2000, Argentina

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Adelaide, New South Wales, 5011, Australia

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Gosford, New South Wales, 2250, Australia

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Kogarah, New South Wales, 2217, Australia

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Liverpool, New South Wales, 2170, Australia

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St Leonards, New South Wales, 2065, Australia

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Sydney, New South Wales, 2139, Australia

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Greenslopes, Queensland, 4120, Australia

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Southport, Queensland, 4215, Australia

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Woolloongabba, Queensland, 4102, Australia

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Kurralta Park, South Australia, 5037, Australia

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Frankston, Victoria, 3199, Australia

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Melbourne, Victoria, 3168, Australia

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Vienna, 1090, Austria

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Vienna, 1160, Austria

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Goiânia, Goiás, 74140-050, Brazil

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Belo Horizonte, Minas Gerais, 31270-901, Brazil

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Porto Alegre, Rio Grande do Sul, 90880-480, Brazil

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Santo André, São Paulo, 09060-650, Brazil

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São Paulo, São Paulo, 05403-000, Brazil

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sofia, 1756, Bulgaria

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Varna, 9010, Bulgaria

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Vratsa, 3000, Bulgaria

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Calgary, Alberta, T2N 4N2, Canada

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Edmonton, Alberta, T6G 1Z2, Canada

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Winnipeg, Manitoba, R0C 2Z0, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Barrie, Ontario, L4M 6M2, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Rimouski, Quebec, G5L 5T1, Canada

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Zagreb, 10000, Croatia

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Brno, 625 00, Czechia

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Hradec Králové, 500 05, Czechia

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Prague, 128 08, Czechia

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Aalborg, 9000, Denmark

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Aarhus, 8000, Denmark

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Copenhagen, 2100, Denmark

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Odense, 5000, Denmark

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Vejle, 7100, Denmark

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Cairo, 11796, Egypt

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Angers, 49933, France

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Bobigny, 93009, France

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Caen, 14076, France

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Clermont-Ferrand, 63003, France

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Créteil, 94010, France

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Le Mans, 72015, France

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Lille, 59037, France

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Lyon, 69373, France

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Marseille, 13273, France

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Montpellier, 34295, France

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Nantes, 44093, France

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Paris, 75475, France

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Paris, 75651, France

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Pessac, 33604, France

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Pierre-Bénite, 69495, France

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Poitiers, 86021, France

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Reims, 51092, France

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Rennes, 35033, France

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Rouen, 76038, France

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Toulouse, 31059, France

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Tours, 37044, France

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Vandœuvre-lès-Nancy, 54511, France

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Ahaus, 48683, Germany

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Amberg, 92224, Germany

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Ansbach, 91522, Germany

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Bamberg, 96049, Germany

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Berlin, 12200, Germany

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Bonn, 53113, Germany

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Bremen, 28177, Germany

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Bremen, 28209, Germany

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Bremen, 28239, Germany

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Cologne, 50674, Germany

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Cologne, 50924, Germany

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Delitzsch, 04509, Germany

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Detmold, 32756, Germany

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Dresden, 01127, Germany

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Dresden, 01307, Germany

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Duisburg, 47051, Germany

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Erlangen, 91052, Germany

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Erlangen, 91054, Germany

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Eschweiler, 52249, Germany

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Essen, 45122, Germany

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Essen, 45239, Germany

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Esslingen am Neckar, 73730, Germany

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Frankfurt, 60596, Germany

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Frankfurt (Oder), 15236, Germany

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Frankfurt am Main, 60389, Germany

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Frechen, 50226, Germany

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Freiburg im Breisgau, 79106, Germany

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Giessen, Germany

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Göttingen, 37075, Germany

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Greifswald, 17475, Germany

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Hamburg, 20095, Germany

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Hamburg, 20099, Germany

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Hamburg, 20246, Germany

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Hamburg, 22081, Germany

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Hamburg, 22087, Germany

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Hamburg, 22767, Germany

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Hamm, 59063, Germany

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Hanover, 30449, Germany

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Heidelberg, 69120, Germany

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Homburg/Saar, 66241, Germany

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Kaiserslautern, 67655, Germany

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Karlsruhe, 76133, Germany

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Kempten, 87439, Germany

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Kiel, 24116, Germany

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Koblenz, 56068, Germany

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Kronach, 96317, Germany

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Landshut, 84028, Germany

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Lebach, 66822, Germany

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Leer, 26789, Germany

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Lemgo, 32657, Germany

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Loerrach, 79539, Germany

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Lüdenscheid, 58515, Germany

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Magedburg, 39104, Germany

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Mainz, 55131, Germany

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Mannheim, 68161, Germany

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Mutlangen, 73557, Germany

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München, 80335, Germany

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München, 81241, Germany

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München, 81377, Germany

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München, 81479, Germany

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München, 81675, Germany

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Neunkirchen/Saar, 66538, Germany

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Nuremberg, 90449, Germany

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Oldenburg, 26121, Germany

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Porta Westfalica, 32457, Germany

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Ravensburg, 88212, Germany

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Recklinghausen, 45657, Germany

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Regensburg, 93049, Germany

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Regensburg, 93053, Germany

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Rostock, 18057, Germany

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Rüsselsheim am Main, 65428, Germany

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Saarbrücken, 66113, Germany

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Sindelfingen, 71065, Germany

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Stuttgart, 70199, Germany

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Trier, 54290, Germany

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Tübingen, 72076, Germany

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Ulm, 89081, Germany

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Villingen-Schwenningen, 78052, Germany

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Weilheim, 82362, Germany

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Wendlingen, 73240, Germany

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Witten, 58452, Germany

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Worms, 67547, Germany

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Würzburg, 97080, Germany

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Hong Kong, Hong Kong

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Cagliari, 09121, Italy

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Cosenza, 87100, Italy

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Ferrara, 44100, Italy

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Genova, 16132, Italy

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Messina, 98165, Italy

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Milan, 20132, Italy

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Milan, 20162, Italy

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Modena, 41100, Italy

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Orbassano, 10043, Italy

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Roma, 00144, Italy

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Roma, 00161, Italy

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Roma, 00168, Italy

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Terni, 05100, Italy

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Torino, 10126, Italy

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Aguascalientes, 20127, Mexico

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Culiacán, 80230, Mexico

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Hermosillo, 83000, Mexico

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Monterrey, 64460, Mexico

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San Luis Potosí City, 78218, Mexico

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Delftzijl, 9934 JD, Netherlands

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Enschede, 7511 JX, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Nieuwegein, 3430 EM, Netherlands

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Auckland, 1009, New Zealand

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Christchurch, 8011, New Zealand

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Bucharest, 022328, Romania

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Bucharest, 030171, Romania

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Târgu Mureş, 540136, Romania

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Kazan', 420029, Russia

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Nizhny Novgorod, 603126, Russia

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Penza, 440071, Russia

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Perm, 614077, Russia

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Rostov-on-Don, 344022, Russia

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Ufa, 450005, Russia

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Bratislava, 833 10, Slovakia

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Manresa, Barcelona, 08240, Spain

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Sabadell, Barcelona, 08208, Spain

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Jerez de la Frontera, Cadiz, 11407, Spain

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Santander, Cantabria, 39008, Spain

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Donostia / San Sebastian, Guipuzcoa, 20014, Spain

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A Coruña, LA Coruña, 15006, Spain

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Santiago de Compostela, LA Coruña, 15706, Spain

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Pamplona, Navarre, 31008, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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San Cristóbal de La Laguna, Tenerife, 38320, Spain

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Gandia, Valencia, 46702, Spain

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Barcelona, 08003, Spain

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Barcelona, 08025, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Jaén, 23007, Spain

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Las Palmas, 35020, Spain

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Madrid, 28006, Spain

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Madrid, 28031, Spain

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Madrid, 28033, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Madrid, 28222, Spain

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Madrid, 28905, Spain

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Málaga, 29010, Spain

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Málaga, 29600, Spain

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Murcia, 30008, Spain

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Murcia, 30120, Spain

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Salamanca, 37007, Spain

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Seville, 41014, Spain

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Toledo, 45004, Spain

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Toledo, 45600, Spain

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Valencia, 46009, Spain

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Valencia, 46010, Spain

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Valencia, 46014, Spain

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Valencia, 46015, Spain

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Valencia, 46017, Spain

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Zaragoza, 50009, Spain

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Aarau, 5001, Switzerland

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Basel, 4031, Switzerland

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Bern, 3010, Switzerland

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Chur, 7000, Switzerland

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Lucerne, 6000, Switzerland

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Sankt Gallen, 9007, Switzerland

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Zurich, 8091, Switzerland

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Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Khon Kaen, 40002, Thailand

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Bournemouth, BH7 7DW, United Kingdom

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Cambridge, CB2 0QQ, United Kingdom

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Canterbury, CT1 3NG, United Kingdom

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Cardiff, CF14 4XN, United Kingdom

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Cottingham, HU16 5JG, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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London, EC1M 6BQ, United Kingdom

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London, NW3 2QG, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Sutton, SM2 5PT, United Kingdom

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Related Publications (4)

• 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.

  PMID: 38620092 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.

  PMID: 33131249 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.

  PMID: 31050355 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.

  PMID: 24401022 DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

obinutuzumab; Rituximab; Chlorambucil

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 9, 2009
• Study Start: December 21, 2009
• Primary Completion: July 1, 2012
• Study Completion: August 23, 2017
• Last Updated: September 14, 2018
• Results First Posted: April 1, 2014

Record last verified: 2018-08

Locations

DE (83); RO (3); TH (4); NL (4); BU (5); AU (4); GB (12); EG (1); CH (7); DK (5); AR (7); BR (5); ES (2); CR (1); RU (6); SL (1); US (5); CZ (3); HK (1); NZ (2); CA (8); FR (22); IT (14); ME (5)