Trial · NCT00735930
Lenalidomide and Alvocidib in Treating Patients With Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT00735930, Phase 1, Completed, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lenalidomide and Alvocidib in Treating Patients With Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. Trials, record NCT00735930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00735930
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenalidomide and Alvocidib in Treating Patients With Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- NCT number
- NCT00735930
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 39 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Anemia, Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Thrombocytopenia
- Interventions
- Alvocidib Hydrochloride, Lenalidomide, Pharmacological Study, Laboratory Biomarker Analysis
- First posted
- 2008-08-15
- Last updated
- 2015-04-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MTD of lenalidomide when combined with alvocidib, defined as the maximum dose level with fewer than 2 of 6 patients experiencing dose limiting toxicity (DLT) | Up to day 70 | |
| Primary | Incidence of DLT in patients treated with alvocidib and lenalidomide graded according to NCI CTCAE version 4.0 | Up to day 70 | Toxicities classified as DLT during course 1 will not be considered DLT for the combination of lenalidomide and flavopiridol, but will result in patient removal from the study. |
| Secondary | Pharmacokinetic parameters of alvocidib and lenalidomide alone and in combination in plasma samples | Baseline, day 1 of course 1, and on days 2-3 of course 2 | Samples will be analyzed in batches to assess plasma drug concentrations, the plasma drug concentration-time profile (AUC), volume of distribution (Vss), clearance (CL), and half-life. Standard paired statistical tests, parametric and nonparametric, will be used to compare baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data. |
| Secondary | Plasma IL-6 and selected cytokine levels | Up to 5 years | Standard paired statistical tests, parametric and nonparametric, will be used to compare baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data. |
| Secondary | B-cell activation as assessed by surface antigen (CD40, CD80, CD86, HLA-DR, and CD95) expression | Up to 5 years | Standard paired statistical tests, parametric and nonparametric, will be used to compare baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data. |
| Secondary | Intracellular pharmacodynamic targets including STAT3, Mcl-1, and nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) | Up to 5 years | Standard paired statistical tests, parametric and nonparametric, will be used to compare baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data. |
| Secondary | Response assessed by National Cancer Institute-Sponsored Working Group guidelines | Up to 5 years | Standard paired statistical tests, parametric and nonparametric, will be used to compare baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data. |
| Secondary | Progression-free survival (PFS) | Time from start of treatment to time of progression, assessed up to 5 years | Standard paired statistical tests, parametric and nonparametric, will be used to compare baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data. |
| Secondary | Toxicity graded according to NCI CTCAE version 4.0 | Up to 5 years | Standard paired statistical tests, parametric and nonparametric, will be used to compare baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data. |
| Secondary | Presence of minimal residual disease | Up to 5 years | Standard paired statistical tests, parametric and nonparametric, will be used to compare baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00735930
GET https://conductscience.org/api/trials/v1/NCT00735930/registered