Trial · NCT01998880
CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)
NCT01998880, Phase 3, Completed, Hoffmann-La Roche; results first posted 2014-01-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b). Trials, record NCT01998880. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01998880
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)
- NCT number
- NCT01998880
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 787 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Lymphocytic Leukemia, Chronic
- Interventions
- obinutuzumab, rituximab, chlorambucil
- First posted
- 2013-12-02
- Last updated
- 2018-09-14
- Results first posted
- 2014-01-28
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 57.7 months) | PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by 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 57.7 months) | Percentage of Participants with Progression Free Survival Events: progression, relapse, or death. |
| Secondary | Event Free Survival | Randomization to clinical cutoff (median observation 57.7 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 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 57.7 months) | Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause. |
| Secondary | Percentage of Participants With End of Treatment Response (EOTR) | Randomization to clinical cutoff (median observation 57.7 months) | 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. |
| Secondary | Percentage of Participants With Molecular Remission at the End of Treatment | Randomization to clinical cutoff (median observation 57.7 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 CLL cell in 10000 leukocytes (MRD value \< 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR). |
| Secondary | Progression Free Survival Based on Independent Review Committee (IRC) Data | Randomization to clinical cutoff date of 9 May 2013 (median observation 22.7 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 date of 9 May 2013 (median observation 22.7 months) | Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee. |
| Secondary | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score | Baseline and Cycle 4 Day 1 (Cy4D1) | 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. |
| Secondary | European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score | Baseline and Cycle 4 Day 1 (Cy4D1) | 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. |
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 57.7 months) | Intent-to-treat population included all randomized participants. Patients without PFS events were censored. | Months | MEDIAN |
| PRIMARY | Percentage of Participants With Progression Free Survival Events | Randomization to clinical cutoff (median observation 57.7 months) | Intent-to-treat population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Event Free Survival | Randomization to clinical cutoff (median observation 57.7 months) | Intent-to-treat population included all randomized participants. Patients without EFS events were censored. | Months | MEDIAN |
| SECONDARY | Overall Survival | Randomization to clinical cutoff (median observation 57.7 months) | Intent-to-treat population included all randomized participants. Patients without OS events were censored. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With End of Treatment Response (EOTR) | Randomization to clinical cutoff (median observation 57.7 months) | Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Molecular Remission at the End of Treatment | Randomization to clinical cutoff (median observation 57.7 months) | Participants from the Intent-to-treat population (all randomized participants) with MRD data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival Based on Independent Review Committee (IRC) Data | Randomization to clinical cutoff date of 9 May 2013 (median observation 22.7 months) | Intent-to-treat population included all randomized participants. Patients without PFS events were censored. | months | MEDIAN |
| SECONDARY | 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 22.7 months) | Intent-to-treat population included all randomized participants. Participants without PFS events were censored. | Percentage of participants | NUMBER |
| SECONDARY | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score | Baseline and Cycle 4 Day 1 (Cy4D1) | ITT population. Here, n signifies the number of participants who were evaluated for specified categories. | unit on a scale | MEAN |
| SECONDARY | European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score | Baseline and Cycle 4 Day 1 (Cy4D1) | ITT population. Here, n signifies the number of participants who were evaluated for specified categories. | unit on a scale | MEAN |
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) | 16.5 | 95% Confidence Interval 14.3 to 17.7 | Months | |
| Progression-free Survival (PFS) | Chlorambucil (Clb) | 11.1 | 95% Confidence Interval 10.7 to 11.3 | Months | |
| Percentage of Participants With Progression Free Survival Events | Rituximab + Chlorambucil (RClb) | 90.1 | Percentage of participants | ||
| Percentage of Participants With Progression Free Survival Events | Chlorambucil (Clb) | 90.7 | Percentage of participants | ||
| Event Free Survival | Rituximab + Chlorambucil (RClb) | 15.7 | 95% Confidence Interval 14.2 to 17.2 | Months | |
| Event Free Survival | Chlorambucil (Clb) | 10.8 | 95% Confidence Interval 8.0 to 11.1 | Months | |
| Overall Survival | Rituximab + Chlorambucil (RClb) | 74.9 | 95% Confidence Interval 60.8 to NA | Months | |
| Overall Survival | Chlorambucil (Clb) | 66.7 | 95% Confidence Interval 50.9 to NA | Months | |
| Percentage of Participants With End of Treatment Response (EOTR) | Rituximab + Chlorambucil (RClb) | Complete Response (CR) | 4.7 | 95% Confidence Interval 2.4 to 8.3 | Percentage of participants |
| Percentage of Participants With End of Treatment Response (EOTR) | Chlorambucil (Clb) | Complete Response (CR) | 0.0 | 95% Confidence Interval 0.0 to 3.1 | 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) | 233 | |
| Overall Study | STARTED | Chlorambucil (Clb) | 118 | |
| Overall Study | Received Study Drug | Rituximab + Chlorambucil (RClb) | 230 | |
| Overall Study | Received Study Drug | Chlorambucil (Clb) | 116 | |
| Overall Study | COMPLETED | Rituximab + Chlorambucil (RClb) | 205 | |
| Overall Study | COMPLETED | Chlorambucil (Clb) | 78 | |
| Overall Study | NOT COMPLETED | Rituximab + Chlorambucil (RClb) | 28 | |
| Overall Study | NOT COMPLETED | Chlorambucil (Clb) | 40 |
Source ClinicalTrials.gov
Adverse events312
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) | 71 | 225 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chlorambucil (Clb) | 21 | 116 | |
| other | Anaemia | Blood and lymphatic system disorders | Rituximab + Chlorambucil (RClb) | 28 | 225 | |
| other | Anaemia | Blood and lymphatic system disorders | Chlorambucil (Clb) | 12 | 116 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab + Chlorambucil (RClb) | 16 | 225 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chlorambucil (Clb) | 9 | 116 | |
| other | Nausea | Gastrointestinal disorders | Rituximab + Chlorambucil (RClb) | 32 | 225 | |
| other | Nausea | Gastrointestinal disorders | Chlorambucil (Clb) | 29 | 116 | |
| other | Diarrhoea | Gastrointestinal disorders | Rituximab + Chlorambucil (RClb) | 19 | 225 | |
| other | Diarrhoea | Gastrointestinal disorders | Chlorambucil (Clb) | 13 | 116 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 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 | Chlorambucil (Clb) | ||
| Total, other adverse events | Rituximab + Chlorambucil (RClb) | 202 | 225 |
| Total, other adverse events | Chlorambucil (Clb) | 89 | 116 |
| Total, serious adverse events | Rituximab + Chlorambucil (RClb) | 87 | 225 |
| Total, serious adverse events | Chlorambucil (Clb) | 45 | 116 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 Chlorambucil (Clb): 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/NCT01998880
GET https://conductscience.org/api/trials/v1/NCT01998880/results?page=2