Trial · NCT02053610
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
NCT02053610, Phase 3, Completed, Hoffmann-La Roche; results first posted 2014-10-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2). Trials, record NCT02053610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02053610
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
- NCT number
- NCT02053610
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 787 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Lymphocytic Leukemia, Chronic
- Interventions
- obinutuzumab, rituximab, chlorambucil
- First posted
- 2014-02-03
- Last updated
- 2018-09-14
- Results first posted
- 2014-10-10
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Randomization to clinical cutoff (median observation 59.4 months) | 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). |
| Primary | Percentage of Participants With Progression Free Survival Events | Randomization to clinical cutoff (median observation 59.4 months) | Percentage of Participants with Progression Free Survival Events: progression, relapse, or death. |
| Secondary | Progression Free Survival Based on Independent Review Committee (IRC) Data | Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months) | 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). |
| Secondary | Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data | Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months) | Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee. |
| Secondary | Percentage of Participants With End of Treatment Response (EOTR) | Randomization to clinical cutoff (median observation 59.4 months) | EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. Complete Response (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. Partial Response (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. |
| Secondary | Percentage of Participants With Best Overall Response | Randomization to clinical cutoff (median observation 59.4 months) | Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi, PR or nodular Partial Response (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. |
| Secondary | Event Free Survival | Randomization to clinical cutoff (median observation 59.4 months) | 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). |
| Secondary | Overall Survival | Randomization to clinical cutoff (median observation 59.4 months) | Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause. |
| Secondary | Duration of Response | Randomization to clinical cutoff (median observation 59.4 months) | 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. |
| Secondary | Percentage of Participants With Molecular Remission at the End of Treatment | Randomization to clinical cutoff (median observation 59.4 months) | 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). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Randomization to clinical cutoff (median observation 59.4 months) | Intent--to-treat population (ITT) included all randomized participants. Data for patients without disease progression or death was censored at the time of the last response assessment, or, if no response assessments were performed after the baseline visit, at the time of randomization plus one day. | months | MEDIAN |
| PRIMARY | Percentage of Participants With Progression Free Survival Events | Randomization to clinical cutoff (median observation 59.4 months) | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival Based on Independent Review Committee (IRC) Data | Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months) | Intent-to-treat population (ITT) included all randomized participants. Data for patients without disease progression or death was censored at the time of the last response assessment, or, if no response assessments were performed after the baseline visit, at the time of randomization plus one day. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data | Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months) | ITT participants included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With End of Treatment Response (EOTR) | Randomization to clinical cutoff (median observation 59.4 months) | Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response | Randomization to clinical cutoff (median observation 59.4 months) | Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | Event Free Survival | Randomization to clinical cutoff (median observation 59.4 months) | ITT population included all randomized participants. Participants were censored at the date of last tumor assessment. In cases where no tumor assessment is available, participants were censored at the date of randomization plus one day. | months | MEDIAN |
| SECONDARY | Overall Survival | Randomization to clinical cutoff (median observation 59.4 months) | ITT population included all randomized participants. Participants who were not reported as having died at the time of the analysis were censored at the date when they were last known to be alive. | months | MEDIAN |
| SECONDARY | Duration of Response | Randomization to clinical cutoff (median observation 59.4 months) | Participants from the ITT population, all randomized participants, with response. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Molecular Remission at the End of Treatment | Randomization to clinical cutoff (median observation 59.4 months) | Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group130
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Rituximab + Chlorambucil (RClb) | 15.7 | 95% Confidence Interval 14.3 to 17.2 | months | |
| Progression-free Survival (PFS) | Obinutuzumab + Chlorambucil (GClb) | 28.9 | 95% Confidence Interval 26.1 to 32.7 | months | |
| Percentage of Participants With Progression Free Survival Events | Rituximab + Chlorambucil (RClb) | 88.5 | percentage of participants | ||
| Percentage of Participants With Progression Free Survival Events | Obinutuzumab + Chlorambucil (GClb) | 73.3 | percentage of participants | ||
| Progression Free Survival Based on Independent Review Committee (IRC) Data | Rituximab + Chlorambucil (RClb) | 14.9 | 95% Confidence Interval 14.2 to 17.2 | months | |
| Progression Free Survival Based on Independent Review Committee (IRC) Data | Obinutuzumab + Chlorambucil (GClb) | 26.7 | 95% Confidence Interval 23.2 to 31.1 | months | |
| Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data | Rituximab + Chlorambucil (RClb) | 55.5 | percentage of participants | ||
| Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data | Obinutuzumab + Chlorambucil (GClb) | 30.9 | percentage of participants | ||
| Percentage of Participants With End of Treatment Response (EOTR) | Rituximab + Chlorambucil (RClb) | Complete Response (CR) | 4.8 | 95% Confidence Interval 2.8 to 7.8 | percentage of participants |
| Percentage of Participants With End of Treatment Response (EOTR) | Obinutuzumab + Chlorambucil (GClb) | Complete Response (CR) | 15.6 | 95% Confidence Interval 11.9 to 20 | percentage of participants |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab + Chlorambucil (RClb) | 330 | |
| Overall Study | STARTED | Obinutuzumab + Chlorambucil (GClb) | 333 | |
| Overall Study | Received Study Drug | Rituximab + Chlorambucil (RClb) | 326 | |
| Overall Study | Received Study Drug | Obinutuzumab + Chlorambucil (GClb) | 331 | |
| Overall Study | COMPLETED | Rituximab + Chlorambucil (RClb) | 288 | |
| Overall Study | COMPLETED | Obinutuzumab + Chlorambucil (GClb) | 266 | |
| Overall Study | NOT COMPLETED | Rituximab + Chlorambucil (RClb) | 42 | |
| Overall Study | NOT COMPLETED | Obinutuzumab + Chlorambucil (GClb) | 67 |
Source ClinicalTrials.gov
Adverse events478
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab + Chlorambucil (RClb) | 104 | 321 | |
| other | Neutropenia | Blood and lymphatic system disorders | Obinutuzumab + Chlorambucil (GClb) | 128 | 336 | |
| other | Anaemia | Blood and lymphatic system disorders | Rituximab + Chlorambucil (RClb) | 34 | 321 | |
| other | Anaemia | Blood and lymphatic system disorders | Obinutuzumab + Chlorambucil (GClb) | 33 | 336 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab + Chlorambucil (RClb) | 20 | 321 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Obinutuzumab + Chlorambucil (GClb) | 46 | 336 | |
| other | Leukopenia | Blood and lymphatic system disorders | Rituximab + Chlorambucil (RClb) | 7 | 321 | |
| other | Leukopenia | Blood and lymphatic system disorders | Obinutuzumab + Chlorambucil (GClb) | 21 | 336 | |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Rituximab + Chlorambucil (RClb) | 118 | 321 | |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Obinutuzumab + Chlorambucil (GClb) | 197 | 336 |
1 to 10 of 478Source ClinicalTrials.gov
See all 478 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab + Chlorambucil (RClb) | ||
| Total, all-cause mortality | Obinutuzumab + Chlorambucil (GClb) | ||
| Total, other adverse events | Rituximab + Chlorambucil (RClb) | 279 | 321 |
| Total, other adverse events | Obinutuzumab + Chlorambucil (GClb) | 299 | 336 |
| Total, serious adverse events | Rituximab + Chlorambucil (RClb) | 124 | 321 |
| Total, serious adverse events | Obinutuzumab + Chlorambucil (GClb) | 150 | 336 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29255066 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rituximab + Chlorambucil (RClb) vs Obinutuzumab + Chlorambucil (GClb): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02053610
GET https://conductscience.org/api/trials/v1/NCT02053610/results?page=2