Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-31 @ 10:09 PM
Study NCT ID:
NCT01076556
Status:
TERMINATED
Last Update Posted:
2015-11-11
First Post:
2010-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyclophosphamide, Alvocidib, and Rituximab in Treating Patients With High Risk B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase I Feasibility Trial of Cyclophosphamide, Alvocidib (Flavopiridol) and Rituximab (CAR) in Patients With High Risk B-cell CLL/SLL
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial is studying the side effects and the best dose of alvocidib when given together with cyclophosphamide and rituximab in treating patients with high risk B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Alvocidib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can also block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Other find cancer cells and help kill them or carry cancer-killing substances to them. Giving cyclophosphamide, alvocidib, and rituximab together may kill more cancer cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the dose-limiting toxicity and maximum-tolerated dose of treatment with cyclophosphamide, alvocidib, and rituximab in patients with high-risk B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
II. To determine the feasibility of administering this regimen as an outpatient regimen in these patients.
SECONDARY OBJECTIVES:
I. To determine the complete response rate, partial response rate, and minimal-residual disease-negative response rate in patients treated with this regimen.
II. To determine the pharmacokinetics of alvocidib and dexamethasone as part of this regimen.
III. To determine the immunologic effects of this regimen as measured by serial T-cell and NK-cell number, T-cell function, and immunoglobulin levels.
OUTLINE: This is a dose-escalation study of alvocidib.
Patients receive rituximab IV over 4 hours on days 1 (days 1-3 in course 1), cyclophosphamide IV over 30-60 minutes on days 1-3, and alvocidib IV over 4.5 hours on days 1 and 8 (day 8 only in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically for pharmacokinetic and pharmacodynamic studies.
After completion of study treatment, patients are followed up for up to 5 years.
I. To determine the dose-limiting toxicity and maximum-tolerated dose of treatment with cyclophosphamide, alvocidib, and rituximab in patients with high-risk B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
II. To determine the feasibility of administering this regimen as an outpatient regimen in these patients.
SECONDARY OBJECTIVES:
I. To determine the complete response rate, partial response rate, and minimal-residual disease-negative response rate in patients treated with this regimen.
II. To determine the pharmacokinetics of alvocidib and dexamethasone as part of this regimen.
III. To determine the immunologic effects of this regimen as measured by serial T-cell and NK-cell number, T-cell function, and immunoglobulin levels.
OUTLINE: This is a dose-escalation study of alvocidib.
Patients receive rituximab IV over 4 hours on days 1 (days 1-3 in course 1), cyclophosphamide IV over 30-60 minutes on days 1-3, and alvocidib IV over 4.5 hours on days 1 and 8 (day 8 only in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically for pharmacokinetic and pharmacodynamic studies.
After completion of study treatment, patients are followed up for up to 5 years.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| OSU-09089 | None | None | View | |
| OSU 09089 | OTHER | Ohio State University Comprehensive Cancer Center | View | |
| 8267 | OTHER | CTEP | View | |
| P30CA016058 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA076576 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2011-01373 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| OSU 09089 | None | None | View | |
| CDR0000666448 | None | None | View |