Trial · NCT00058240
Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
NCT00058240, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-06-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma. Trials, record NCT00058240. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00058240
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
- NCT number
- NCT00058240
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- B-cell Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Waldenström Macroglobulinemia
- Interventions
- alvocidib
- First posted
- 2003-04-09
- Last updated
- 2017-07-02
- Results first posted
- 2017-06-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Dose Limiting Toxicities (DLTs) | up to 7 weeks | DLTs were defined as non-hematologic toxicity of grade 3 or greater severity (excluding transient liver function abnormalities, transient electrolyte abnormalities that are not life threatening, fatigue, or diarrhea that resolve within 4 days), or in some case grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity). Hematologic toxicity were evaluated by the modified NCI criteria and followed closely. Dose limiting only if grade 4 thrombocytopenia or neutropenia persists for 7 days or greater. Inability to continue with cycle 2 by 7 weeks for reasons other than progression of disease will also be considered a DLT.The National Cancer Institute Common Toxicity Criteria will be used to characterize toxicity. |
| Primary | Recommended Dose Level of Flavopiridol | Up to 6 weeks | Recommended dose determined by number of DLTs \[non-hematologic toxicity grade 3 or greater (excluding not life-threatening transient liver function or transient electrolyte abnormalities, fatigue, or diarrhea resolving within 4 days), some grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity), hematologic toxicity of grade 4 thrombocytopenia/neutropenia persisting for 7 days or greater, or inability to continue cycle 2 by 7 weeks for reasons other than disease progression\] and consideration of number of patients with severe tumor lysis requiring hemodialysis with dose 1. |
| Secondary | Overall Response Rate (CR + PR) of Flavopiridol in Patients Evaluated Utilizing the Revised National Cancer Institute-sponsored Working Group Guidelines | Up to 2 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Dose Limiting Toxicities (DLTs) | up to 7 weeks | patients | NUMBER | |
| PRIMARY | Recommended Dose Level of Flavopiridol | Up to 6 weeks | mg/m^2 | NUMBER | |
| SECONDARY | Overall Response Rate (CR + PR) of Flavopiridol in Patients Evaluated Utilizing the Revised National Cancer Institute-sponsored Working Group Guidelines | Up to 2 years | patients | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Dose Limiting Toxicities (DLTs) | Dose Level 1 | 2 | patients | ||
| Number of Patients With Dose Limiting Toxicities (DLTs) | Dose Level 2 | 2 | patients | ||
| Number of Patients With Dose Limiting Toxicities (DLTs) | Dose Level 3 | 4 | patients | ||
| Number of Patients With Dose Limiting Toxicities (DLTs) | Dose Level 4 | 3 | patients | ||
| Recommended Dose Level of Flavopiridol | Dose Level 4 | Cycle 1 dose 1 | 30 | mg/m^2 | |
| Recommended Dose Level of Flavopiridol | Dose Level 4 | Cycle 1 dose 2 thru Cycle 6 | 50 | mg/m^2 | |
| Overall Response Rate (CR + PR) of Flavopiridol in Patients Evaluated Utilizing the Revised National Cancer Institute-sponsored Working Group Guidelines | Dose Level 1, 2, 3, 4 | 21 | patients |
Source ClinicalTrials.gov
Participant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Dose Level | STARTED | Dose Level 1 | 20 | |
| First Dose Level | STARTED | Dose Level 2 | 3 | |
| First Dose Level | STARTED | Dose Level 3 | 17 | |
| First Dose Level | STARTED | Dose Level 4 | 12 | |
| First Dose Level | Treated | Dose Level 1 | 20 | |
| First Dose Level | Treated | Dose Level 2 | 3 | |
| First Dose Level | Treated | Dose Level 3 | 17 | |
| First Dose Level | Treated | Dose Level 4 | 12 | |
| First Dose Level | COMPLETED | Dose Level 1 | 20 | |
| First Dose Level | COMPLETED | Dose Level 2 | 3 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events36
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 | Absolute Neutrophil Count | Investigations | Dose Levels 1-3 | 30 | 40 | 30 |
| other | Absolute Neutrophil Count | Investigations | Dose Level 4 | 16 | 16 | 16 |
| other | WBC | Investigations | Dose Levels 1-3 | 0 | 40 | 0 |
| other | WBC | Investigations | Dose Level 4 | 11 | 16 | 11 |
| other | Platelets | Investigations | Dose Levels 1-3 | 15 | 40 | 15 |
| other | Platelets | Investigations | Dose Level 4 | 7 | 16 | 7 |
| other | Hemorhage | Vascular disorders | Dose Levels 1-3 | 3 | 40 | 3 |
| other | Hemorhage | Vascular disorders | Dose Level 4 | 1 | 16 | 1 |
| other | Hypotension | Vascular disorders | Dose Levels 1-3 | 4 | 40 | 4 |
| other | Hypotension | Vascular disorders | Dose Level 4 | 1 | 16 | 1 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Levels 1-3 | ||
| Total, all-cause mortality | Dose Level 4 | ||
| Total, other adverse events | Dose Levels 1-3 | 40 | 40 |
| Total, other adverse events | Dose Level 4 | 16 | 16 |
| Total, serious adverse events | Dose Levels 1-3 | 11 | 42 |
| Total, serious adverse events | Dose Level 4 | 1 | 16 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants3
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA016058 | Cancer Center Support Grant | RATHMELL, WENDY KIMRYN | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| U01CA076576 | Phase I Trials of Anti-Cancer Agents | GREVER, MICHAEL R | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1998 to 2013 | NIH RePORTER |
| R21CA112947 | A Novel Dosing Schedule of Flavopiridol in CLL | LIN, THOMAS S | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2005 to 2006 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dose Levels 1-3 vs Dose Level 4: serious adverse events |
Source Trial comparisons
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/NCT00058240
GET https://conductscience.org/api/trials/v1/NCT00058240/flow?page=2