Trial · NCT00281918
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Median observation time at time of analysis was approximately 21 months | Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first. |
| Primary | Final Analysis: Time to Progression-free Survival Event | Median observation time was approximately 66.4 months | Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first. |
| Secondary | Event-free Survival (EFS) | Median observation time at time of analysis was approximately 21 months | Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause. |
| Secondary | Overall Survival (OS) | Median observation time at time of analysis was approximately 21 months | Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached. |
| Secondary | Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR). | Median observation time at time of analysis was approximately 21 months | CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached. |
| Secondary | Final Analysis: Time to Overall Survival Event | Median observation time was approximately 66.4 months | Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. |
| Secondary | Final Analysis: Time to Event-free Survival Event | Median observation time was approximately 66.4 months | Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause. |
| Secondary | Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR) | Median observation time was approximately 66.4 months | CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death |
| Secondary | Final Analysis: Duration of Response | Median observation time was approximately 66.4 months | Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause. |
| Secondary | Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response | Median observation time was approximately 66.4 months | CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. |
| Secondary | Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL) | Median observation time was approximately 66.4 months | The time from randomization to the start of a new treatment. |
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
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GET https://conductscience.org/api/trials/v1/NCT00281918/registered