Trial · NCT02242942
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria | Baseline until disease progression or death up to approximately 3.75 years | PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of PD or death from any cause. Disease progression was characterized by at least one of the following: 1) \>/= 50% increase in the absolute number of circulating lymphocytes to at least 5\*10\^9/L, 2) Appearance of new palpable lymph nodes (\> 15 mm in longest diameter) or any new extra-nodal lesion; 3) \>/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) \>/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology. |
| Secondary | Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria | Baseline until disease progression or death up to approximately 3.75 years | PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) \>/= 50% increase in the absolute number of circulating lymphocytes to at least 5\*10\^9/L, 2) Appearance of new palpable lymph nodes (\> 15 mm in longest diameter) or any new extra-nodal lesion; 3) \>/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) \>/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology. |
| Secondary | Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria | At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months) | OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: \>/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, \>/=50% reduction in lymphadenopathy, \>/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L. |
| Secondary | Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria | At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months) | CRR was defined as the rate of a clinical response of CR or CRi according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). |
| Secondary | Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood as Measured by Allele-Specific Oligonucleotide Polymerase Chain Reaction (ASO-PCR) at Completion of Treatment | At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months) | MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in peripheral blood. |
| Secondary | Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment | At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months) | MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in bone marrow. |
| Secondary | Overall Survival (OS) | Baseline until death, up to approximately 10.75 years | 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 MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment | Day 1 Cycle 9 or 3 months after last IV infusion, approximately 9 months | MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in peripheral blood. |
| Secondary | Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment | Day 1 Cycle 9 or 3 months after last IV infusion at approximately 9 months | MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in bone marrow. |
| Secondary | Percentage of Participants With OR at Completion of Combination Treatment Response Assessment | Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months | OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L. PR: two of the following features for at least 2 months: \>/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, \>/=50% reduction in lymphadenopathy, \>/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L. |
| Secondary | Duration of Objective Response (DOR) | Time from the first occurrence of a documented objective response to the time of PD as determined by the investigator or death from any cause, up to approximately 10.75 years | PD was defined as lymphadenopathy, \>=50% increase in liver or spleen size, \>=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. |
| Secondary | Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD) | Baseline up to the completion of treatment assessment 3 months after treatment completion (up to approximately 15 months) | CR: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: \>/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, \>/=50% reduction in lymphadenopathy, \>/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L. PD: lymphadenopathy, \>=50% increase in liver or spleen size, \>=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD. |
| Secondary | Event-Free Survival | Time between date of randomization and the date of disease progression/relapse on the basis of investigator-assessment, death, or start of a new anti-leukemic therapy, up to 10.75 years | |
| Secondary | Time to Next Anti-Leukemic Treatment | Time between the date of randomization and the date of first intake of new anti-leukemic therapy, up to 10.75 years | |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to approximately 10.75 years | An AE 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 AE 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 AEs. |
| Secondary | Percentage of Participants With CD19 + /CD5+ B Cells or CD14+ Monocytes | Baseline up to approximately 10.75 years | |
| Secondary | Percentage of Participants With Human-Anti-Human Antibodies | Baseline up to approximately 10.75 years | |
| Secondary | Percentage of Participants Recorded as Premature Study Withdrawals | Up to approximately 10.75 years | |
| Secondary | Plasma Concentrations of Venetoclax | Pre-venetoclax dose (0 hour) and 4 hours post- venetoclax dose on Day 1 Cycle 4 | |
| Secondary | Serum Concentrations of Obinutuzumab | Pre-obinutuzumab infusion (0 hour) and end of obinutuzumab infusion on Day 1 Cycle 4 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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