Trial · NCT01178086
A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
NCT01178086, Completed, Hoffmann-La Roche; results first posted 2018-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL). Trials, record NCT01178086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01178086
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
- NCT number
- NCT01178086
- Status
- Completed
- Enrollment
- 681 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Lymphocytic Leukemia, Chronic
- Interventions
- Rituximab
- First posted
- 2010-08-09
- Last updated
- 2018-10-05
- Results first posted
- 2018-10-05
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) | PFS was defined as the time from initiation of treatment with rituximab in combination with chemotherapy to disease progression or death due to any cause, whichever occurred first. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (\>/=) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes. Participants without disease progression or death at the time of analysis were censored at the last date of tumor evaluation in terms of PFS. |
| Primary | Percentage of Participants Without Progression or Death | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) | Disease progression was defined as the occurrence of at least one of the following: \>/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes. |
| Secondary | Percentage of Participants With Progression and Death | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) | Percentage of participants with an event (progression or death) was reported. Disease progression was defined as the occurrence of at least one of the following: \>/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes. |
| Secondary | Percentage of Participants Who Received Each Treatment During the Course of Study | Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month) | The chemotherapeutic regimen administereted during the course of study were: Rituximab-Bendamustine (R-Benda), Rituximab-Fludarabine-Cyclophosphamide (R-FC), Rituximab-Clorambucil (R-Clb), R-Other and Rituximab mono. |
| Secondary | Mean Body Weight | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) | |
| Secondary | Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) | ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair \>50% of waking hours. |
| Secondary | Percentage of Participants With Karnofsky Performance Status Index | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) | Performance status was reflected by the Karnofsky index. Karnofsky performance status index ranges from 0-100% with higher scores indicating better functional status. An index between 90% and 100% corresponds to ECOG grade 0, index between 70% and 80% corresponds to ECOG grade 1, index between 50% and 60% corresponds to ECOG grade 2, index 40% corresponds to ECOG grade 3. ECOG grade 0=Fully active, able to carry on all pre-disease activities without restriction; grade 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; grade 2=Ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; grade 3=Capable of only limited self-care, confined to bed/chair \>50% of waking hours. |
| Secondary | Percentage of Participants With General Symptoms | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) | General symptoms included fatigue, reduced performance, frequent infections, abdominal pain and exhaustion. |
| Secondary | Percentage of Participants With B-Symptoms | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) | B-symptoms included fever, night sweats, weight loss. |
| Secondary | Percentage of Participants With Best Overall Response (BOR) | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) | Response to treatment was assessed as per clinical routine. BOR included complete response(CR or CR with incomplete hematopoietic regeneration),partial response(PR or nodular PR),stable disease(SD),progressive disease(PD). CR:hemoglobin\>/=11 grams/deciliter(g/dL), lymphocytes\<4000 cells/cubic millimeter(cells/mm\^3), neutrophils\>5000 cells/mm\^3,platelets\>100,000 cells/mm\^3,bone marrow biopsy with \<30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, performance status of 0. PR:\>50% decrease in size of enlarged lymph nodes, hepatomegaly, splenomegaly, with peripheral counts meeting same criteria as CR or \>/=50% improvement from pre-treatment values.PD:occurrence of at least one of following: \>/=50% increase in longest diameter of at least 2 enlarged lymph nodes, increase in spleen and liver size by at least 2 cm from Baseline, or \>/=50% increase in number of circulating lymphocytes. Participants without CR/PR or PD were considered having SD. |
Source ClinicalTrials.gov
Outcomes10
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) as Assessed Using Kaplan-Meier Estimate | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) | Analysis was performed on EAS. | months | MEDIAN |
| PRIMARY | Percentage of Participants Without Progression or Death | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) | Analysis was performed on EAS. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Progression and Death | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) | Analysis was performed on EAS with events. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Received Each Treatment During the Course of Study | Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month) | Analysis was performed on EAS. | percentage of participants | NUMBER |
| SECONDARY | Mean Body Weight | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) | Analysis was performed on EAS. Overall number of participants analyzed=participants analyzed for this outcome. Here, number analyzed=participants evaluable at specified time-point. | kilograms (kg) | MEAN |
| SECONDARY | Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) | Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Karnofsky Performance Status Index | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) | Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With General Symptoms | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) | Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With B-Symptoms | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) | Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) | Analysis was performed on EAS. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group252
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) as Assessed Using Kaplan-Meier Estimate | Unselected Population (Participants With Any Comorbidity) | 50.6 | 95% Confidence Interval 42.4 to 59.6 | months | |
| Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate | Slow Go Subpopulation | 33.7 | 95% Confidence Interval 26.2 to NA | months | |
| Percentage of Participants Without Progression or Death | Unselected Population (Participants With Any Comorbidity) | 71.1 | 95% Confidence Interval 66.1 to 75.5 | percentage of participants | |
| Percentage of Participants Without Progression or Death | Slow Go Subpopulation | 62.7 | 95% Confidence Interval 53.9 to 70.3 | percentage of participants | |
| Percentage of Participants With Progression and Death | Unselected Population (Participants With Any Comorbidity) | Progression | 68.9 | percentage of participants | |
| Percentage of Participants With Progression and Death | Slow Go Subpopulation | Progression | 66.7 | percentage of participants | |
| Percentage of Participants With Progression and Death | Unselected Population (Participants With Any Comorbidity) | Death | 31.1 | percentage of participants | |
| Percentage of Participants With Progression and Death | Slow Go Subpopulation | Death | 33.3 | percentage of participants | |
| Percentage of Participants Who Received Each Treatment During the Course of Study | Unselected Population (Participants With Any Comorbidity) | R-Benda at Baseline | 58.5 | percentage of participants | |
| Percentage of Participants Who Received Each Treatment During the Course of Study | Slow Go Subpopulation | R-Benda at Baseline | 64.0 | percentage of participants |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With Chonic Lymphatic Leukemia (CLL) | 681 | |
| Overall Study | Effectiveness Analysis Set (EAS) | Participants With Chonic Lymphatic Leukemia (CLL) | 661 | |
| Overall Study | COMPLETED | Participants With Chonic Lymphatic Leukemia (CLL) | 349 | |
| Overall Study | NOT COMPLETED | Participants With Chonic Lymphatic Leukemia (CLL) | 332 |
Source ClinicalTrials.gov
Adverse events244
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 | Anemia | Blood and lymphatic system disorders | Unselected Population (Participants With Any Comorbidity) | 40 | 485 | |
| other | Anemia | Blood and lymphatic system disorders | Slow Go Subpopulation | 21 | 196 | |
| other | Leukopenia | Blood and lymphatic system disorders | Unselected Population (Participants With Any Comorbidity) | 129 | 485 | |
| other | Leukopenia | Blood and lymphatic system disorders | Slow Go Subpopulation | 48 | 196 | |
| other | Neutropenia | Blood and lymphatic system disorders | Unselected Population (Participants With Any Comorbidity) | 33 | 485 | |
| other | Neutropenia | Blood and lymphatic system disorders | Slow Go Subpopulation | 15 | 196 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Unselected Population (Participants With Any Comorbidity) | 99 | 485 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Slow Go Subpopulation | 31 | 196 | |
| other | Diarrhoea | Gastrointestinal disorders | Unselected Population (Participants With Any Comorbidity) | 26 | 485 | |
| other | Diarrhoea | Gastrointestinal disorders | Slow Go Subpopulation | 14 | 196 |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Unselected Population (Participants With Any Comorbidity) | ||
| Total, all-cause mortality | Slow Go Subpopulation | ||
| Total, other adverse events | Unselected Population (Participants With Any Comorbidity) | 259 | 485 |
| Total, other adverse events | Slow Go Subpopulation | 98 | 196 |
| Total, serious adverse events | Unselected Population (Participants With Any Comorbidity) | 85 | 485 |
| Total, serious adverse events | Slow Go Subpopulation | 44 | 196 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29393986 | 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 |
|---|
| Unselected Population (Participants With Any Comorbidity) vs Slow Go Subpopulation: 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.
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