Trial · NCT00445341
Flavopiridol to Treat Relapsed Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma
NCT00445341, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2012-10-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Flavopiridol to Treat Relapsed Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma. Trials, record NCT00445341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00445341
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Flavopiridol to Treat Relapsed Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma
- NCT number
- NCT00445341
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Lymphoma
- Interventions
- Flavopiridol
- First posted
- 2007-03-09
- Last updated
- 2018-01-30
- Results first posted
- 2012-10-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (e.g. Toxicity) | 47 months | Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. |
| Primary | Response Rate (Complete Response (CR) and Partial Response (PR)) | 2/16/2007 - 1/20/2011 | Response was assessed by the Cheson criteria. Complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g.(LDH) definitely assignable to the lymphoma. All lymph nodes must have regressed to normal size (\</= 1.5 cm in greatest diameter if \> 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to \</= 1 cm or by more than 75% in the sum of the products of the greatest diameters (SPD). Spleen, if considered to be enlarged before therapy, must have regressed in size. Partial response is a \>/= 50% decrease in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by \>/= 50% in the SPD. Bone marrow is irrelevant for determination of a PR. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (e.g. Toxicity) | 47 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Response Rate (Complete Response (CR) and Partial Response (PR)) | 2/16/2007 - 1/20/2011 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (e.g. Toxicity) | Flavopiridol in Lymphoma Patients | 28 | Participants | ||
| Response Rate (Complete Response (CR) and Partial Response (PR)) | Flavopiridol in Lymphoma Patients | Complete Response | 0 | Participants | |
| Response Rate (Complete Response (CR) and Partial Response (PR)) | Flavopiridol in Lymphoma Patients | Partial Response | 2 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Flavopiridol in Lymphoma Patients | 28 | |
| Overall Study | COMPLETED | Flavopiridol in Lymphoma Patients | 26 | |
| Overall Study | NOT COMPLETED | Flavopiridol in Lymphoma Patients | 2 |
Source ClinicalTrials.gov
Adverse events121
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 | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Flavopiridol in Lymphoma Patients | 13 | 28 | 47 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Flavopiridol in Lymphoma Patients | 22 | 28 | 84 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Flavopiridol in Lymphoma Patients | 23 | 28 | 136 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Flavopiridol in Lymphoma Patients | 16 | 28 | 33 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Flavopiridol in Lymphoma Patients | 1 | 28 | 1 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Flavopiridol in Lymphoma Patients | 1 | 28 | 1 |
| other | Anorexia | Gastrointestinal disorders | Flavopiridol in Lymphoma Patients | 8 | 28 | 8 |
| other | Bicarbonate, serum-low | Metabolism and nutrition disorders | Flavopiridol in Lymphoma Patients | 9 | 28 | 13 |
| other | Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | Flavopiridol in Lymphoma Patients | 12 | 28 | 31 |
| other | CPK (creatine phosphokinase) | Metabolism and nutrition disorders | Flavopiridol in Lymphoma Patients | 4 | 28 | 6 |
1 to 10 of 121Source ClinicalTrials.gov
See all 121 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Flavopiridol in Lymphoma Patients | 0 | 28 |
| Total, other adverse events | Flavopiridol in Lymphoma Patients | 28 | 28 |
| Total, serious adverse events | Flavopiridol in Lymphoma Patients | 14 | 28 |
Source ClinicalTrials.gov
Papers3
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/NCT00445341
GET https://conductscience.org/api/trials/v1/NCT00445341/events?page=2