Trial · NCT00824265
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS), as Assessed by the Independent Review Committee (IRC) | From randomization up to 5 years after last dose of study drug | Intent-to-Treat (ITT) Population: all participants randomized and received study drug. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization up to 5 years after last dose of study drug | ITT Population. | Months | MEDIAN |
| SECONDARY | Time to Response, as Assessed by the IRC | From randomization up to 5 years after last dose of study drug | ITT Population. Participants with unknown or missing responses were considered as non-responders. Only responders were included in the analysis. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR), as Assessed by the IRC | From time of initial response to disease progression or death, whichever came first (up to 5 years after the last dose of study drug) | ITT Population. Par with unknown or missing responses were considered as non-responders, only responders were included in this analysis. | Months | MEDIAN |
| SECONDARY | Time to Progression, as Assessed by the IRC | From randomization up to 5 years after the last dose of study drug | ITT Population. | Months | MEDIAN |
| SECONDARY | Time to Next Therapy | From the start of study drug until the start of the next anti-CLL therapy (up to 5 years after the last dose of study drug) | ITT Population | Months | MEDIAN |
| SECONDARY | Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status | Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day1, follow up (FU) at 1Month (M) after study drug therapy, 3M, then every 3 month up to 5 year (up to 60 months) | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Participants | NUMBER |
| SECONDARY | Number of Participants With no B-Symptoms or at Least One B-symptoms Over the Time | Screening, Cycle1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and During at 1M after study drug therapy, 3M, then every 3 M up to 5 year (up to 60 months) | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Participants | NUMBER |
| SECONDARY | Percentage of Participants With the Best Overall Response (OR), as Assessed by the IRC | From randomization up to 5 years after last dose of study drug | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With the Best OR, as Assessed by the Investigator | From randomization up to 5 years after last dose of study drug | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Were Negative for Minimal Residual Disease (MRD) Assessed by IRC | From randomization up to 5 years after last dose of study drug | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Participants | NUMBER |
| SECONDARY | Number of Participants Who Were Negative for MRD Assessed by Investigator | From randomization up to 5 years after last dose of study drug | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Participants | NUMBER |
| SECONDARY | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | From first dose of study medication to 60 Days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE) | Safety Population: Participants who received at least one dose of a study drug. | Participants | NUMBER |
| SECONDARY | Number of Participants With a Human Anti-human Antibody (HAHA) Positive Result at Indicated Time Points | From start of study drug until 60 days after the last dose of study medication | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles) | Participants | NUMBER |
| SECONDARY | Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) | From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE) | Safety Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Drug Related Infections Reported as AEs and SAEs of Maximum Severity of Grade 3 or Higher | From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE) | Safety Population | Participants | NUMBER |
| SECONDARY | Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression Adverse Events | From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE) | Safety Population | Participants | NUMBER |
| SECONDARY | Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study | From randomization up to 5 years after last dose of study drug | Safety Population | Participants | NUMBER |
| SECONDARY | Mean Level of Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM | Baseline, 1M and 6M follow up | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Gram per liter | MEAN |
| SECONDARY | Change From Baseline in Cluster of Differentiation (CD) Cell Counts, CD5+ and CD19+ | Screening, Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and after last dose at 1 M and then every three months up to 45 M during Follow-up Period | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | cells/uL | MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00824265/outcomes