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NCT00445341 · ClinicalTrials.gov registry record · Phase 1
Flavopiridol to Treat Relapsed Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00445341: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00445341 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00445341, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Background: Mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma (DLBCL) are aggressive subtypes of non-Hodgkin lymphoma. Flavopiridol is an investigational drug that works differently from standard chemotherapy and may target abnormalities in MCL and DLBCL cells, such as a protein excess that prevents tumor cells from dying. A challenge in developing flavopiridol for treatment has been determining its optimal dosing schedule. The schedule used for this study is effective in a type of leukemia called chronic lymphocytic leukemia (CLL) and may benefit patients with MCL and DLBCL also. Objectives: To determine the highest dose of flavopiridol that can be given safely to patients with relapsed MCL and DLBCL at the dosing schedule detailed below To assess the response of the tumor to flavopiridol given at the test dosing schedule Eligibility: Patients 18 years of age and older with relapsed MCL or DLBCL Design: Flavopiridol is given at four different dose levels, starting with the lowest dose for the first group of three to six patients and increasing with subsequent groups, depending on side effects at the preceding dose. The drug is given weekly for 4 weeks followed by a 2-week break (one cycle) for up to six cycles. It is given through a vein as a 30-minute infusion followed by a 4-hour infusion. Patients undergo the following procedures for research studies and to evaluate the effect of treatment on the tumor: * Blood tests * Lymph node, bone marrow and tumor biopsies * Lymphapheresis to collect blood cells for research * Disease staging with imaging studies (computed tomography (CT), positron emission tomography (PET) and/or magnetic resonance imaging (MRI) after every 2 cycles
Interventions
- DRUG Flavopiridol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2006-11-27 |
| Est. Completion | 2012-10-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00445341
The ClinicalTrials.gov registry entry for NCT00445341 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Flavopiridol is the first listed.
NCT00445341 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00445341 about?
NCT00445341 is a clinical study titled "Flavopiridol to Treat Relapsed Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma". Background: Mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma (DLBCL) are aggressive subtypes of non-Hodgkin lymphoma. Flavopiridol is an investigational drug that works differently from standard chemotherapy and may target abnormalities in MCL and DLBCL cells, such as a protein excess ...
What is the current status of trial NCT00445341?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2006-11-27. Estimated completion is 2012-10-18.
What interventions are being tested in trial NCT00445341?
The interventions under investigation include: Flavopiridol (DRUG).
Who is sponsoring clinical trial NCT00445341?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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