Trial · NCT01905943
A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
NCT01905943, Phase 3, Completed, Hoffmann-La Roche; results first posted 2018-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia. Trials, record NCT01905943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01905943
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
- NCT number
- NCT01905943
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 979 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Bendamustine, Chlorambucil, Cyclophosphamide, Fludarabine, Obinutuzumab
- First posted
- 2013-07-23
- Last updated
- 2019-10-28
- Other registries' IDs
- eudract:2013-000087-29
- Results first posted
- 2018-10-29
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | Baseline up to time of primary completion (3 years) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest and AEs of Particular Interest, were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs). |
| Primary | Number of Participants With Adverse Events of Special Interest (AESIs) | Baseline up to time of primary completion (3 years) | The following AEs were defined as AESIs: AEs with the preferred term Tumour Lysis Syndrome (TLS), Infusion-Related Reactions (IRRs) defined as AEs that occurred during or within 24 hours of the completion of obinutuzumab infusion and were assessed as related to obinutuzumab by the Investigator, Infections defined as AEs from System Organ Class (SOC) "Infections and infestations" and AEs with the preferred term Neutropenia. Reported are number of participants with total AESIs, IRRs, Infections, Neutropenia and TLS. |
| Primary | Number of Participants With Adverse Events of Particular Interest (AEPIs) | Baseline up to time of primary completion (3 years) | The following AEs were defined as AEPIs: AEs with the preferred term Progressive multifocal leukoencephalopathy (PML), hepatitis B reactivation defined as AEs with preferred term containing "Hepatitis B" or "hepatitis acute", thrombocytopenia defined via Roche MedDRA basket subgroup "haematopoietic thrombocytopenia", second malignancies defined as AEs from the SOC "Neoplasms benign, malignant and unspecified" starting 6 months after the first study drug intake, second malignancies based on standardised MedDRA queries (SMQ) starting 6 months after the first study drug intake based on the MedDRA SMQ "Malignant or unspecified tumours", in which benign neoplasms are not included, Cardiac events including AEs from the SOC "Cardiac disorders", and hemorrhagic events defined via Roche MedDRA basket subgroup "Haemorrhagic events". Reported are number of participants with total AEPIs and each of the AEPI categories. |
| Secondary | Percentage of Participants With Overall Response (OR) at Final Response Assessment (FRA) | 3 months after the last dose of study treatment (up to approximately 5 years) | OR: percentage of participants with complete response (CR) or CR with incomplete marrow recovery (CRi), or partial response (PR), as determined by the investigator based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) tumor response criteria. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils \>1,500/mcL, platelets \> 100,000/mcL, hemoglobin \> 110 g/L and bone marrow normocellular for age. Cri: CR with persistent cytopenia. PR: \>/= 50% decrease in peripheral blood lymphocyte count AND \>/= 50% reduction in lymphadenopathy OR \>/= 50% reduction of liver enlargement OR \>/= 50% reduction of spleen PLUS one of the following: neutrophils \>1,500/mcL, platelets \> 100,000/mcL, hemoglobin \> 110 g/L OR \>/= 50% increase in neutrophils, platelets or hemoglobin. |
| Secondary | Percentage of Participants With Minimal Residual Disease (MRD)-Negativity as Assessed by Flow Cytometry | 3 months after the last dose of study treatment (up to approximately 5 years) | MRD-negativity was defined as the presence of less than 1 chronic lymphocytic leukemia (CLL) cell per 10,000 leukocytes in blood and bone marrow as assessed by flow cytometry 3 months after last dose of study treatment (i.e. at final response assessment \[FRA\] visit). |
| Secondary | Percentage of Participants With Best Overall Response (BOR) | Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years) | BOR was defined as the percentage of participants with the best response obtained throughout the trial with CR, CRi, or PR, as determined by the investigator based on IWCLL tumor response criteria. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils \>1,500/mcL, platelets \> 100,000/mcL, hemoglobin \> 110 g/L and bone marrow normocellular for age. Cri: CR with persistent cytopenia. PR: \>/= 50% decrease in peripheral blood lymphocyte count AND \>/= 50% reduction in lymphadenopathy OR \>/= 50% reduction of liver enlargement OR \>/= 50% reduction of spleen PLUS one of the following: neutrophils \>1,500/mcL, platelets \> 100,000/mcL, hemoglobin \> 110 g/L OR \>/= 50% increase in neutrophils, platelets or hemoglobin. |
| Secondary | Median Time to Progression-Free Survival (PFS) | Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years) | Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]) based on IWCLL tumor response criteria or died from any cause, whichever occurred first. PD: at least one of the following: \>/= 50% increase in the absolute number of circulating lymphocytes to at least 5,000/mcL, appearance of new palpable lymph nodes, \>/= 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 more aggressive histology, progression of any cytopenia, decrease of hemoglobin levels by more than 20 g/L or to less than 100 g/L, decrease of platelet counts by more than 50% or to less than 100,000 /mcL, decrease of neutrophil counts by more than 50% or to less than 1,000/mcL. |
| Secondary | Median Time to Response (TTR) | Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years) | Kaplan Meier estimate of median TTR was defined as the time at which half of the participants reached CR or PR based on IWCLL tumor response criteria. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils \>1,500/mcL, platelets \> 100,000/mcL, hemoglobin \> 110 g/L and bone marrow normocellular for age. PR: \>/= 50% decrease in peripheral blood lymphocyte count AND \>/= 50% reduction in lymphadenopathy OR \>/= 50% reduction of liver enlargement OR \>/= 50% reduction of spleen PLUS one of the following: neutrophils \>1,500/mcL, platelets \> 100,000/mcL, hemoglobin \> 110 g/L OR \>/= 50% increase in neutrophils, platelets or hemoglobin. |
| Secondary | Median Time to Event-Free Survival (EFS) | Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years) | Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed as assessed by investigator based on IWCLL tumor response criteria, or have initiated a non-protocol-specified anti-leukemia therapy or died, whichever occurs first. PD: at least 1 of the following: \>/= 50% increase in absolute number of circulating lymphocytes to at least 5,000/mcL, appearance of new palpable lymph nodes, \>/= 50% increase in longest diameter of any previous site of clinically significant lymphadenopathy, \>/= 50% increase in enlargement of liver and/or spleen, transformation to more aggressive histology, progression of any cytopenia, decrease of hemoglobin levels by more than 20 g/L or to less than 100 g/L, decrease of platelet counts by more than 50% or to less than 100,000 /mcL, decrease of neutrophil counts by more than 50% or to less than 1,000/mcL. |
| Secondary | Median Time to Overall Survival (OS) | Baseline until death (Approximately up to 5 years) | Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | Baseline up to time of primary completion (3 years) | The safety population was defined as all participants who have received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events of Special Interest (AESIs) | Baseline up to time of primary completion (3 years) | The safety population was defined as all participants who have received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events of Particular Interest (AEPIs) | Baseline up to time of primary completion (3 years) | The safety population was defined as all participants who have received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Overall Response (OR) at Final Response Assessment (FRA) | 3 months after the last dose of study treatment (up to approximately 5 years) | The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Minimal Residual Disease (MRD)-Negativity as Assessed by Flow Cytometry | 3 months after the last dose of study treatment (up to approximately 5 years) | The intent-to-ship (ITS) population included all participants from the ITT population whose MRD samples at the FRA could be shipped to the central laboratory within 48 hours. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) | Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years) | The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug. | percentage of participants | NUMBER |
| SECONDARY | Median Time to Progression-Free Survival (PFS) | Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years) | The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug. | months | MEDIAN |
| SECONDARY | Median Time to Response (TTR) | Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years) | The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug. | months | MEDIAN |
| SECONDARY | Median Time to Event-Free Survival (EFS) | Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years) | The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug. | months | MEDIAN |
| SECONDARY | Median Time to Overall Survival (OS) | Baseline until death (Approximately up to 5 years) | The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug. | months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group134
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | Obinutuzumab | AEs | 950 | Participants | |
| Number of Participants With Adverse Events (AEs) | Obinutuzumab | Grade 3-5 AEs | 780 | Participants | |
| Number of Participants With Adverse Events (AEs) | Obinutuzumab | SAEs | 516 | Participants | |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Obinutuzumab | Total AESIs | 905 | Participants | |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Obinutuzumab | IRRs | 635 | Participants | |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Obinutuzumab | Neutropenia | 599 | Participants | |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Obinutuzumab | Infections | 521 | Participants | |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Obinutuzumab | TLS | 62 | Participants | |
| Number of Participants With Adverse Events of Particular Interest (AEPIs) | Obinutuzumab | Total AEPIs | 467 | Participants | |
| Number of Participants With Adverse Events of Particular Interest (AEPIs) | Obinutuzumab | Thrombocytopenia | 314 | Participants |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Obinutuzumab | 972 | |
| Overall Study | COMPLETED | Obinutuzumab | 658 | |
| Overall Study | NOT COMPLETED | Obinutuzumab | 314 |
Source ClinicalTrials.gov
Adverse events1,780
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 | Anaemia | Blood and lymphatic system disorders | G-Mono | 19 | 127 | 28 |
| other | Anaemia | Blood and lymphatic system disorders | G-Benda | 134 | 537 | 174 |
| other | Anaemia | Blood and lymphatic system disorders | G-FC | 50 | 193 | 76 |
| other | Anaemia | Blood and lymphatic system disorders | G-Clb | 27 | 114 | 35 |
| other | Leukopenia | Blood and lymphatic system disorders | G-Mono | 7 | 127 | 10 |
| other | Leukopenia | Blood and lymphatic system disorders | G-Benda | 70 | 537 | 119 |
| other | Leukopenia | Blood and lymphatic system disorders | G-FC | 27 | 193 | 45 |
| other | Leukopenia | Blood and lymphatic system disorders | G-Clb | 8 | 114 | 12 |
| other | Neutropenia | Blood and lymphatic system disorders | G-Mono | 45 | 127 | 130 |
| other | Neutropenia | Blood and lymphatic system disorders | G-Benda | 288 | 537 | 645 |
1 to 10 of 1,780Source ClinicalTrials.gov
See all 1,780 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | G-Mono | ||
| Total, all-cause mortality | G-Benda | ||
| Total, all-cause mortality | G-FC | ||
| Total, all-cause mortality | G-Clb | ||
| Total, other adverse events | G-Mono | 108 | 127 |
| Total, other adverse events | G-Benda | 503 | 537 |
| Total, other adverse events | G-FC | 184 | 193 |
| Total, other adverse events | G-Clb | 107 | 114 |
| Total, serious adverse events | G-Mono | 71 | 127 |
| Total, serious adverse events | G-Benda | 335 | 537 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01905943
GET https://conductscience.org/api/trials/v1/NCT01905943/results?page=2