Trial · NCT00112723
Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma
NCT00112723, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2016-08-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma. Trials, record NCT00112723. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00112723
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma
- NCT number
- NCT00112723
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Multiple Myeloma, Splenic Marginal Zone Lymphoma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma, Waldenström Macroglobulinemia
- Interventions
- alvocidib
- First posted
- 2005-06-03
- Last updated
- 2016-08-08
- Results first posted
- 2016-08-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I) | 28 days | Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy. |
| Primary | Maximum Tolerated Dose (MTD) | 28 days | The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT. |
| Primary | Complete and Partial Response Rate (Phase II) | Up to 2 years | Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria. |
| Primary | Qualitative and Quantitative Toxicities in Regard to Organ Specificity | Up to 30 days after completion of study treatment | The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients. |
| Primary | Lymphoid/Plasma Cell Malignancies | Up to 2 years | Identify subsets, based on levels of response (PR and SD), of lymphoid / plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of flavopiridol. |
| Secondary | Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1 | Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion. |
| Secondary | Number of Patients Reporting Acute Infusion Toxicity (e.g., Fever, Hypotension, Tumor Pain, and Dyspnea) | Up to 30 days after completion of study treatment | |
| Secondary | Induced Response in Patients Independent of p53 Mutational Status | 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. |
| Secondary | Pharmacodynamic Effects of Flavopiridol on Normal Peripheral Blood Mononuclear Cells (PBMCs). | Day 1 | The correlation of the pharmacodynamic effects of flavopiridol on normal peripheral blood mononuclear cells (PBMCs) |
| Secondary | Pharmacokinetics (Cmax) of Flavopiridol | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1 | Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I) | 28 days | patients | NUMBER | |
| PRIMARY | Maximum Tolerated Dose (MTD) | 28 days | mg/m2 | NUMBER | |
| PRIMARY | Complete and Partial Response Rate (Phase II) | Up to 2 years | Includes patients enrolled with Indolent B-cell NHL, Intermediate Grade B NHL, Mantle cell NHL and T/NK-cell NHL | patients | NUMBER |
| PRIMARY | Qualitative and Quantitative Toxicities in Regard to Organ Specificity | Up to 30 days after completion of study treatment | Grade 3 and 4 toxicities. | percentage of patients | NUMBER |
| PRIMARY | Lymphoid/Plasma Cell Malignancies | Up to 2 years | Response indicated for Indolent B-cell NHL, Mantle cell NHL and T-cell NHL | patients | NUMBER |
| SECONDARY | Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1 | total of 71 PK (Pharmacokinetic) profiles comprising 484 plasma concentration were determined for 45 of 46 patients following treatment | hr×μM | MEAN |
| SECONDARY | Number of Patients Reporting Acute Infusion Toxicity (e.g., Fever, Hypotension, Tumor Pain, and Dyspnea) | Up to 30 days after completion of study treatment | patients | NUMBER | |
| SECONDARY | Induced Response in Patients Independent of p53 Mutational Status | Up to 2 years | Data not available due to studies were not conducted by collaborating laboratory Investigator | ||
| SECONDARY | Pharmacodynamic Effects of Flavopiridol on Normal Peripheral Blood Mononuclear Cells (PBMCs). | Day 1 | Data not available due to studies were not conducted by collaborating laboratory Investigator | ||
| SECONDARY | Pharmacokinetics (Cmax) of Flavopiridol | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1 | μM | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I) | Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) | 0 | patients | ||
| Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I) | Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) | 0 | patients | ||
| Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I) | Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2) | 0 | patients | ||
| Maximum Tolerated Dose (MTD) | Dose Level 1 (30+30) | 60 | mg/m2 | ||
| Maximum Tolerated Dose (MTD) | Level 2 (30+50) | 80 | mg/m2 | ||
| Maximum Tolerated Dose (MTD) | Level 3 (50+50) | 100 | mg/m2 | ||
| Complete and Partial Response Rate (Phase II) | Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) | Complete Response | 0 | patients | |
| Complete and Partial Response Rate (Phase II) | Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) | Complete Response | 0 | patients | |
| Complete and Partial Response Rate (Phase II) | Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2) | Complete Response | 0 | patients | |
| Complete and Partial Response Rate (Phase II) | Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) | Partial Response | 2 | patients |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) | 13 | |
| Overall Study | STARTED | Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) | 19 | |
| Overall Study | STARTED | Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2) | 14 | |
| Overall Study | Patients Evaluable for Toxicity | Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) | 11 | |
| Overall Study | Patients Evaluable for Toxicity | Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) | 12 | |
| Overall Study | Patients Evaluable for Toxicity | Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2) | 12 | |
| Overall Study | COMPLETED | Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) | 11 | |
| Overall Study | COMPLETED | Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) | 12 | |
| Overall Study | COMPLETED | Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2) | 12 | |
| Overall Study | NOT COMPLETED | Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events16
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 | Leukopenia | Investigations | Treatment (Alvocidib) | 30 | 35 | 30 |
| other | Neutropenia | Investigations | Treatment (Alvocidib) | 34 | 35 | 34 |
| other | Lymphopenia | Investigations | Treatment (Alvocidib) | 25 | 35 | 25 |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Alvocidib) | 22 | 35 | 22 |
| other | Thrombocytopenia | Injury, poisoning and procedural complications | Treatment (Alvocidib) | 13 | 35 | 13 |
| other | Infection | Infections and infestations | Treatment (Alvocidib) | 9 | 35 | 9 |
| other | Neutropenia fever | General disorders | Treatment (Alvocidib) | 4 | 35 | 4 |
| other | Increased ALT/AST | Investigations | Treatment (Alvocidib) | 12 | 35 | 12 |
| other | Hyperbilirubinemia | Investigations | Treatment (Alvocidib) | 6 | 35 | 6 |
| other | Nausea | Gastrointestinal disorders | Treatment (Alvocidib) | 12 | 35 | 12 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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) | 34 | 35 |
| Total, serious adverse events | Treatment (Alvocidib) | 0 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24241210 | DERIVED |
Source PubMed
Grants2
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 |
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/NCT00112723
GET https://conductscience.org/api/trials/v1/NCT00112723/results?page=2