Trial · NCT00098371
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response (CR) Rate | Up to 8 months | Patients were assessed for clinical response after two, four and six cycles. | percent of patients | NUMBER |
| PRIMARY | Overall Response Rate (CR + PR) | Up to 8 months | Schedule was amended (cycle length) from 42 to 28 days, reduction in the number of doses per cycle from 4 to 3 and administration of prophylactic dexamethasone 20 mg IV on each treatment day. | percent of patients | NUMBER |
| PRIMARY | Response Duration | Up to 8 months | Duration of response was not collected for patients. | ||
| PRIMARY | Progression-free Survival (PFS) for Responding Patients as Assessed Using Standard Kaplan-Meier Methods | Up to 5 years | months | MEDIAN | |
| PRIMARY | Progression-free Survival for All Patients as Assessed Using Standard Kaplan-Meier Methods | Up to 5 years | months | MEDIAN | |
| PRIMARY | Overall Survival | Up to 5 years | months | MEDIAN | |
| PRIMARY | Toxicity | Measurement prior to each infusion, at end of therapy, 2 months post-completion and post-treatment follow-up every 3 months for two years. | Grade 3 to 4 infections requiring IV antibiotics and were generally related to upper or lower respiratory infections or infections of indwelling central venous catheters. | percentage of patients | NUMBER |
| SECONDARY | Pharmacokinetics (PK) (AUC) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol | During treatment day 1 and day 8 of cycle 1 | The values are overall averages for all patients on days 1 and 8 - therefore, there is only a single value for each parameter. | μM*hr | MEAN |
| SECONDARY | PK (Cmax) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol | During treatment day 1 and day 8 of course 1 | The values are overall averages for all patients on days 1 and 8 - therefore, there is only a single value for each parameter. | μM | MEAN |
| SECONDARY | PK as Assessed by Levels of Both Flavopiridol and Metabolites of Flavopiridol in Urine Samples | Urine collected at 4 separate times in some patients during the first 24 hours after start of infusion on day 1 of course 1. | Data for this PK analysis was not collected and analyzed. | ||
| SECONDARY | Serial Levels of IL-6 as Assessed by Blood Plasma | 4.5 hours, 8 hours, 12 hours, and 24 hours following the initiation of therapy during day 1 of course 1 | IL-6 expression analysis was available for only day 1 and not day 8. | pg/ml | MEAN |
| SECONDARY | Comparison of CLL Cell Samples Taken at Registration/Diagnosis to CLL Cell Samples Taken at Time of Relapse | At baseline and at time of relapse or when patient goes off therapy due to disease progression | Data for this outcome as not collected and analyzed | ||
| SECONDARY | Correlation of Adverse Prognostic Factors With Response to Flavopiridol Treatment as Assessed by Interphase Cytogenetics, VH Mutational Status, ZAP-70 Protein Expression, CD38, and p53 | up to 8 months | Data were not collected and analyzed for VH mutational status, ZAP-70 protein expression, CD38, and p53 | percentage of patients in each subgroup | NUMBER |
| SECONDARY | Levels of Mcl-1 mRNA, Mcl-1 Protein, HIF-1alpha Protein, HIF-1alpha mRNA, NF-kappaB Activation, Total IkB, IkB Phosphorylation, GSK-beta Activity, and IL-6 Target Genes (i.e., STAT3) | At baseline, 4.5 hours (end of continuous infusion), 8 hours, and approximately 24 hours following initiation of therapy | Data was not collected and analyzed for this outcome | ||
| SECONDARY | Comparison of Clinical Response and Tumor Lysis in Vivo With Drug-induced Apoptosis and Mitochondrial Perturbation in Vitro as Assessed by Flow Cytometry | At baseline | A subset of patients who had sufficient material were analyzed according to response only. | percentage of priming cells | 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
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GET https://conductscience.org/api/trials/v1/NCT00098371/outcomes