Trial · NCT00098371
Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
NCT00098371, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2016-10-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia. Trials, record NCT00098371. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00098371
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
- NCT number
- NCT00098371
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- B-cell Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
- Interventions
- alvocidib
- First posted
- 2004-12-08
- Last updated
- 2016-10-24
- Results first posted
- 2016-10-24
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate | Up to 8 months | CR requires all of the following for at least two months from completion of therapy: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC (complete blood count) as exhibited by polymorphonuclear leukocytes \> 1500/µL, platelets \> 100,000/µL, hemoglobin \> 11.0 g/dl (untransfused); lymphocyte count \< 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with \< 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. |
| Primary | Overall Response Rate (CR + PR) | Up to 8 months | CR requires all of the following: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC as exhibited by polymorphonuclear leukocytes \> 1500/µL, platelets \> 100,000/µL, hemoglobin \> 11.0 g/dl (untransfused); lymphocyte count \< 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with \< 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. Patients with CR after induction but wih treatment-related persistent cytopenia is a PR. PR requires a \> 50% decrease in peripheral lymphocyte count from pretreatment value, \> 50% reduction in lymphadenopathy, and/or \> 50% reduction in splenomegaly/hepatomegaly. These patients must have one of the following: polymorphonuclear leukocytes \> 1,500/μL , platelets \> 100,000/μL, hemoglobin \> 11.0 g/dl (untransfused) or any with 50% improvement from pretreatment value. |
| Primary | Response Duration | Up to 8 months | Response evaluation criteria based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response. Descriptive statistics will be computed (median, range, mean, standard deviation, minimum, and maximum) on response duration. |
| Primary | Progression-free Survival (PFS) for Responding Patients as Assessed Using Standard Kaplan-Meier Methods | Up to 5 years | PFS was calculated from the date of study entry until time of disease progression or death, whichever came first, censoring patients alive and relapse free at last follow up. Patients who withdrew from study to undergo an allogeneic SCT (Stem cell transplantation) were censored at the time of transplantation. |
| Primary | Progression-free Survival for All Patients as Assessed Using Standard Kaplan-Meier Methods | Up to 5 years | PFS was calculated from the date of study entry until time of disease progression or death, whichever came first, censoring patients alive and relapse free at last follow up. Patients who withdrew from study to undergo an allogeneic SCT were censored at the time of transplantation. |
| Primary | Overall Survival | Up to 5 years | Overall survival data will be reported on a 3-month basis for 5 years |
| 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. | Toxicity determination based on NCI Common Toxicity Criteria version 3 and modified NCI Common toxicity guidelines for evaluating hematologic toxicity in leukemia. |
| 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 | Pharmacokinetics were performed on day 1 and day 8 of cycle 1 by plasma levels of both flavopiridol and metabolites of flavopiridol using Area Under the Curve (AUC) |
| 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 | Pharmacokinetics were performed on day 1 and day 8 of cycle 1 by plasma levels of both flavopiridol and metabolites of flavopiridol |
| 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. | urine samples were collected in some patients during the first 24 hours after the start of the infusion on cycle 1, day 1 to isolate metabolites of flavopiridol to be used as internal standard for plasma metabolite quantification experiments. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response (CR) Rate | Treatment (Alvocidib) | 2 | percent of patients | ||
| Overall Response Rate (CR + PR) | Treatment (Alvocidib) | 53 | 95% Confidence Interval 41 to 65 | percent of patients | |
| Progression-free Survival (PFS) for Responding Patients as Assessed Using Standard Kaplan-Meier Methods | Treatment (Alvocidib) | 12 | 95% Confidence Interval 8.5 to 13.1 | months | |
| Progression-free Survival for All Patients as Assessed Using Standard Kaplan-Meier Methods | Treatment (Alvocidib) | 8.6 | 95% Confidence Interval 6.7 to 12.6 | months | |
| Overall Survival | Treatment (Alvocidib) | 28.8 | 95% Confidence Interval 18.6 to 32.9 | months | |
| Toxicity | Treatment (Alvocidib) | 25 | percentage of patients | ||
| Pharmacokinetics (PK) (AUC) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol | Treatment (Alvocidib) | 9.42 | Standard Deviation 5.11 | μM*hr | |
| PK (Cmax) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol | Treatment (Alvocidib) | 2.04 | Standard Deviation 1.05 | μM | |
| Serial Levels of IL-6 as Assessed by Blood Plasma | Group 1 | 4.5 hours | 3.5 | 95% Confidence Interval 2.7 to 4.6 | pg/ml |
| Serial Levels of IL-6 as Assessed by Blood Plasma | Group 2 | 4.5 hours | 1.6 | 95% Confidence Interval 1.2 to 2.0 | pg/ml |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Alvocidib) | 64 | |
| Overall Study | COMPLETED | Treatment (Alvocidib) | 64 | |
| Overall Study | NOT COMPLETED | Treatment (Alvocidib) | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Neutropenia | Investigations | Treatment (Alvocidib) | 62 | 64 | 62 |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Alvocidib) | 38 | 64 | 38 |
| other | Thrombocytopenia | Injury, poisoning and procedural complications | Treatment (Alvocidib) | 42 | 64 | 42 |
| other | Fatigue | General disorders | Treatment (Alvocidib) | 60 | 64 | 60 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Alvocidib) | 60 | 64 | 60 |
| other | Nausea and Vomiting | Gastrointestinal disorders | Treatment (Alvocidib) | 48 | 64 | 48 |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Alvocidib) | 20 | 64 | 20 |
| other | Anxiety/Depression | Psychiatric disorders | Treatment (Alvocidib) | 11 | 64 | 11 |
| other | Tumor Lysis Syndrome | Metabolism and nutrition disorders | Treatment (Alvocidib) | 28 | 64 | 28 |
| other | Cytokine Release Syndrome | Immune system disorders | Treatment (Alvocidib) | 27 | 64 | 27 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Alvocidib) | ||
| Total, other adverse events | Treatment (Alvocidib) | 64 | 64 |
| Total, serious adverse events | Treatment (Alvocidib) | 4 | 64 |
Source ClinicalTrials.gov
Papers4
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/NCT00098371
GET https://conductscience.org/api/trials/v1/NCT00098371/results?page=2