AzTrials
AzTrials

Lymphocytic Leukemia, ChronicPhase 3NCT01998880

CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)

A Phase 3 study testing obinutuzumab, rituximab and chlorambucil in people with Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 261 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphocytic Leukemia, Chronic
What is being tested?
obinutuzumab, rituximab and chlorambucil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
787 participants
Where
261 sitesin 26 countries
Study dates
22 Dec 2009to 23 Aug 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

261 sites in 26 countries.

261 sites in 26 countries

Germany83 sites

  • Study site

    Ahaus, 48683

  • Study site

    Amberg, 92224

  • Study site

    Ansbach, 91522

  • Study site

    Bamberg, 96049

  • Study site

    Berlin, 12200

  • Study site

    Bonn, 53113

  • Study site

    Bremen, 28177

  • Study site

    Bremen, 28209

  • Study site

    Bremen, 28239

  • Study site

    Cologne, 50674

  • Study site

    Cologne, 50924

  • Study site

    Delitzsch, 04509

  • Study site

    Detmold, 32756

  • Study site

    Dresden, 01127

  • Study site

    Dresden, 01307

  • Study site

    Duisburg, 47051

  • Study site

    Erlangen, 91052

  • Study site

    Erlangen, 91054

  • Study site

    Eschweiler, 52249

  • Study site

    Essen, 45122

  • Study site

    Essen, 45239

  • Study site

    Esslingen am Neckar, 73730

  • Study site

    Frankfurt, 60596

  • Study site

    Frankfurt (Oder), 15236

  • Study site

    Frankfurt am Main, 60389

  • Study site

    Frechen, 50226

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Giessen

  • Study site

    Göttingen, 37075

  • Study site

    Greifswald, 17475

  • Study site

    Hamburg, 20095

  • Study site

    Hamburg, 20099

  • Study site

    Hamburg, 20246

  • Study site

    Hamburg, 22081

  • Study site

    Hamburg, 22087

  • Study site

    Hamburg, 22767

  • Study site

    Hamm, 59063

  • Study site

    Hanover, 30449

  • Study site

    Heidelberg, 69120

  • Study site

    Homburg/Saar, 66241

  • Study site

    Kaiserslautern, 67655

  • Study site

    Karlsruhe, 76133

  • Study site

    Kempten, 87439

  • Study site

    Kiel, 24116

  • Study site

    Koblenz, 56068

  • Study site

    Kronach, 96317

  • Study site

    Landshut, 84028

  • Study site

    Lebach, 66822

  • Study site

    Leer, 26789

  • Study site

    Lemgo, 32657

  • Study site

    Loerrach, 79539

  • Study site

    Lüdenscheid, 58515

  • Study site

    Magedburg, 39104

  • Study site

    Mainz, 55131

  • Study site

    Mannheim, 68161

  • Study site

    München, 80335

  • Study site

    München, 81241

  • Study site

    München, 81377

  • Study site

    München, 81479

  • Study site

    München, 81675

  • Study site

    Mutlangen, 73557

  • Study site

    Neunkirchen/Saar, 66538

  • Study site

    Nuremberg, 90449

  • Study site

    Oldenburg, 26121

  • Study site

    Porta Westfalica, 32457

  • Study site

    Ravensburg, 88212

  • Study site

    Recklinghausen, 45657

  • Study site

    Regensburg, 93049

  • Study site

    Regensburg, 93053

  • Study site

    Rostock, 18057

  • Study site

    Rüsselsheim am Main, 65428

  • Study site

    Saarbrücken, 66113

  • Study site

    Sindelfingen, 71065

  • Study site

    Stuttgart, 70199

  • Study site

    Trier, 54290

  • Study site

    Tübingen, 72076

  • Study site

    Ulm, 89081

  • Study site

    Villingen-Schwenningen, 78052

  • Study site

    Weilheim, 82362

  • Study site

    Wendlingen, 73240

  • Study site

    Witten, 58452

  • Study site

    Worms, 67547

  • Study site

    Würzburg, 97080

Other trials in Germany

Spain39 sites

  • Study site

    A Coruña, LA Coruña, 15006

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08025

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Study site

    Gandia, Valencia, 46702

  • Study site

    Jaén, 23007

  • Study site

    Jerez de la Frontera, Cadiz, 11407

  • Study site

    Las Palmas, 35020

  • Study site

    Madrid, 28006

  • Study site

    Madrid, 28031

  • Study site

    Madrid, 28033

  • Study site

    Madrid, 28034

  • Study site

    Madrid, 28041

  • Study site

    Madrid, 28046

  • Study site

    Madrid, 28222

  • Study site

    Madrid, 28905

  • Study site

    Málaga, 29010

  • Study site

    Málaga, 29600

  • Study site

    Manresa, Barcelona, 08240

  • Study site

    Murcia, 30008

  • Study site

    Murcia, 30120

  • Study site

    Oviedo, Principality of Asturias, 33006

  • Study site

    Pamplona, Navarre, 31008

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Salamanca, 37007

  • Study site

    San Cristóbal de La Laguna, Tenerife, 38320

  • Study site

    Santander, Cantabria, 39008

  • Study site

    Santiago de Compostela, LA Coruña, 15706

  • Study site

    Seville, 41014

  • Study site

    Toledo, 45004

  • Study site

    Toledo, 45600

  • Study site

    Valencia, 46009

  • Study site

    Valencia, 46010

  • Study site

    Valencia, 46014

  • Study site

    Valencia, 46015

  • Study site

    Valencia, 46017

  • Study site

    Zaragoza, 50009

Other trials in Spain

France22 sites

  • Study site

    Angers, 49933

  • Study site

    Bobigny, 93009

  • Study site

    Caen, 14076

  • Study site

    Clermont-Ferrand, 63003

  • Study site

    Créteil, 94010

  • Study site

    Le Mans, 72015

  • Study site

    Lille, 59037

  • Study site

    Lyon, 69373

  • Study site

    Marseille, 13273

  • Study site

    Montpellier, 34295

  • Study site

    Nantes, 44093

  • Study site

    Paris, 75475

  • Study site

    Paris, 75651

  • Study site

    Pessac, 33604

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Poitiers, 86021

  • Study site

    Reims, 51092

  • Study site

    Rennes, 35033

  • Study site

    Rouen, 76038

  • Study site

    Toulouse, 31059

  • Study site

    Tours, 37044

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy14 sites

  • Study site

    Cagliari, 09121

  • Study site

    Cosenza, 87100

  • Study site

    Ferrara, 44100

  • Study site

    Genova, 16132

  • Study site

    Messina, 98165

  • Study site

    Milan, 20132

  • Study site

    Milan, 20162

  • Study site

    Modena, 41100

  • Study site

    Orbassano, 10043

  • Study site

    Roma, 00144

  • Study site

    Roma, 00161

  • Study site

    Roma, 00168

  • Study site

    Terni, 05100

  • Study site

    Torino, 10126

Other trials in Italy

Australia12 sites

  • Study site

    Adelaide, New South Wales, 5011

  • Study site

    Frankston, Victoria, 3199

  • Study site

    Gosford, New South Wales, 2250

  • Study site

    Greenslopes, Queensland, 4120

  • Study site

    Kogarah, New South Wales, 2217

  • Study site

    Kurralta Park, South Australia, 5037

  • Study site

    Liverpool, New South Wales, 2170

  • Study site

    Melbourne, Victoria, 3168

  • Study site

    Southport, Queensland, 4215

  • Study site

    St Leonards, New South Wales, 2065

  • Study site

    Sydney, New South Wales, 2139

  • Study site

    Woolloongabba, Queensland, 4102

Other trials in Australia

United Kingdom12 sites

  • Study site

    Bournemouth, BH7 7DW

  • Study site

    Cambridge, CB2 0QQ

  • Study site

    Canterbury, CT1 3NG

  • Study site

    Cardiff, CF14 4XN

  • Study site

    Cottingham, HU16 5JG

  • Study site

    Edinburgh, EH4 2XU

  • Study site

    Glasgow, G12 0YN

  • Study site

    Leicester, LE1 5WW

  • Study site

    London, EC1M 6BQ

  • Study site

    London, NW3 2QG

  • Study site

    Nottingham, NG5 1PB

  • Study site

    Sutton, SM2 5PT

Other trials in United Kingdom

Canada8 sites

  • Study site

    Barrie, Ontario, L4M 6M2

  • Study site

    Calgary, Alberta, T2N 4N2

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    Montreal, Quebec, H2L 4M1

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Rimouski, Quebec, G5L 5T1

  • Study site

    Winnipeg, Manitoba, R0C 2Z0

Other trials in Canada

Argentina7 sites

  • Study site

    Buenos Aires, 1406

  • Study site

    Buenos Aires, 1425

  • Study site

    Buenos Aires, C1114AAN

  • Study site

    Buenos Aires, C1180AAX

  • Study site

    Buenos Aires, C1221ADC

  • Study site

    Buenos Aires, C1431FWO

  • Study site

    Rosario, 2000

Other trials in Argentina

Switzerland7 sites

  • Study site

    Aarau, 5001

  • Study site

    Basel, 4031

  • Study site

    Bern, 3010

  • Study site

    Chur, 7000

  • Study site

    Lucerne, 6000

  • Study site

    Sankt Gallen, 9007

  • Study site

    Zurich, 8091

Other trials in Switzerland

Russia6 sites

  • Study site

    Kazan', 420029

  • Study site

    Nizhny Novgorod, 603126

  • Study site

    Penza, 440071

  • Study site

    Perm, 614077

  • Study site

    Rostov-on-Don, 344022

  • Study site

    Ufa, 450005

Other trials in Russia

United States5 sites

  • Study site

    Baltimore, Maryland, 21215

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Green Bay, Wisconsin, 54311

  • Study site

    San Diego, California, 92123

  • Study site

    Waukesha, Wisconsin, 53188

Other trials in United States

Brazil5 sites

  • Study site

    Belo Horizonte, Minas Gerais, 31270-901

  • Study site

    Goiânia, Goiás, 74140-050

  • Study site

    Porto Alegre, Rio Grande do Sul, 90880-480

  • Study site

    Santo André, São Paulo, 09060-650

  • Study site

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Bulgaria5 sites

  • Study site

    Pleven, 5800

  • Study site

    Plovdiv, 4002

  • Study site

    Sofia, 1756

  • Study site

    Varna, 9010

  • Study site

    Vratsa, 3000

Other trials in Bulgaria

Denmark5 sites

  • Study site

    Aalborg, 9000

  • Study site

    Aarhus, 8000

  • Study site

    Copenhagen, 2100

  • Study site

    Odense, 5000

  • Study site

    Vejle, 7100

Other trials in Denmark

Mexico5 sites

  • Study site

    Aguascalientes, 20127

  • Study site

    Culiacán, 80230

  • Study site

    Hermosillo, 83000

  • Study site

    Monterrey, 64460

  • Study site

    San Luis Potosí City, 78218

Other trials in Mexico

Austria4 sites

  • Study site

    Graz, 8036

  • Study site

    Innsbruck, 6020

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1160

Other trials in Austria

Netherlands4 sites

  • Study site

    Delftzijl, 9934 JD

  • Study site

    Enschede, 7511 JX

  • Study site

    Leeuwarden, 8934 AD

  • Study site

    Nieuwegein, 3430 EM

Other trials in Netherlands

Thailand4 sites

  • Study site

    Bangkok, 10330

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

  • Study site

    Khon Kaen, 40002

Other trials in Thailand

Czechia3 sites

  • Study site

    Brno, 625 00

  • Study site

    Hradec Králové, 500 05

  • Study site

    Prague, 128 08

Other trials in Czechia

Romania3 sites

  • Study site

    Bucharest, 022328

  • Study site

    Bucharest, 030171

  • Study site

    Târgu Mureş, 540136

Other trials in Romania

Estonia2 sites

  • Study site

    Tallinn, 13419

  • Study site

    Tartu, 51014

Other trials in Estonia

New Zealand2 sites

  • Study site

    Auckland, 1009

  • Study site

    Christchurch, 8011

Other trials in New Zealand

Croatia1 site

  • Study site

    Zagreb, 10000

Other trials in Croatia

Egypt1 site

  • Study site

    Cairo, 11796

Other trials in Egypt

Hong Kong1 site

  • Study site

    Hong Kong

Other trials in Hong Kong

Slovakia1 site

  • Study site

    Bratislava, 833 10

Other trials in Slovakia

About this study

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

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 (1000mg 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.

Read the detailed description

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.

  • BO21004 (Stage 1a) [NCT01010061] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to chlorambucil (Clb) reported separately.
  • BO21004 (Stage 1b) [NCT01998880] includes the analysis of 2 of the 3 arms rituximab plus chlorambucil (RClb) compared to chlorambucil (Clb) reported here.
  • BO21004 (Stage 2) [NCT02053610] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to rituximab plus chlorambucil (RClb) reported separately.
Being tested
obinutuzumab, rituximab, chlorambucil
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • obinutuzumabDrug

    Also called RO5072759, GA101, GAZYVA®

    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).

  • rituximabDrug

    Also called Rituxan®, MabThera®

    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.

  • chlorambucilDrug

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

Study groups in NCT01998880
Study groupRoleWhat they receive
obinutuzumab + chlorambucil (GClb)ExperimentalParticipants 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).
Receives: Drug: obinutuzumab; Drug: chlorambucil
rituximab + chlorambucil (RClb)Active comparatorParticipants 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).
Receives: Drug: rituximab; Drug: chlorambucil
Chlorambucil (Clb)Active comparatorParticipants 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.
Receives: Drug: chlorambucil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 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).

    Measured: Randomization to clinical cutoff (median observation 57.7 months)

  2. Percentage of Participants With Progression Free Survival Events

    Percentage of Participants with Progression Free Survival Events: progression, relapse, or death.

    Measured: Randomization to clinical cutoff (median observation 57.7 months)

Secondary outcomes (11)

  1. 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 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).

    Measured: Randomization to clinical cutoff (median observation 57.7 months)

  2. Overall Survival

    Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.

    Measured: Randomization to clinical cutoff (median observation 57.7 months)

  3. 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.

    Measured: Randomization to clinical cutoff (median observation 57.7 months)

  4. 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 CLL cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).

    Measured: Randomization to clinical cutoff (median observation 57.7 months)

  5. 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).

    Measured: Randomization to clinical cutoff date of 9 May 2013 (median observation 22.7 months)

  6. 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.

    Measured: Randomization to clinical cutoff date of 9 May 2013 (median observation 22.7 months)

  7. 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.

    Measured: Baseline and Cycle 4 Day 1 (Cy4D1)

  8. 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.

    Measured: Baseline and Cycle 4 Day 1 (Cy4D1)

  9. 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.

    Measured: Randomization to clinical cutoff (median observation 57.7 months)

  10. 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.

    Measured: Randomization to clinical cutoff (median observation 57.7 months)

  11. 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.

    Measured: Randomization to clinical cutoff (median observation 57.7 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2013 (estimated)
  2. Study start22 Dec 2009
  3. Primary completion1 Aug 2012
  4. Study completion23 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
787 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01998880
Sponsor's protocol ID
BO21004 (Stage 1b)
Other IDs
2009-012476-28; CLL1, 2009
Status last verified
Aug 2018
First submitted
25 Nov 2013
Last updated
14 Sep 2018

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing obinutuzumab, rituximab and chlorambucil in people with Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 261 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 261 sites in Germany, Spain, France, Italy, Australia and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Randomization to clinical cutoff (median observation 57.7 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01998880.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.

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