CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Fludarabine Phosphate +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00918723
NCT00918723Phase 2Completed

A Phase I/II Study of Fludarabine, Cyclophosphamide, Rituximab, and Vorinostat Followed by Rituximab and Vorinostat Maintenance Therapy in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Fred Hutchinson Cancer Center·interventional·Posted Jun 11, 2009·Updated Feb 25, 2020

In Brief

A Phase 2 clinical trial evaluating Fludarabine Phosphate, Cyclophosphamide, and 2 other interventions for Chronic Lymphocytic Leukemia and 8 related conditions. Completed, enrolled 40 participants across 2 sites.

Detailed Summary

This phase I/II trial studies the side effects and best dose of vorinostat when given together with fludarabine phosphate, cyclophosphamide, and rituximab and to see how well they work in treating patients with previously untreated B-cell chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving vorinostat together with fludarabine phosphate, cyclophosphamide, and rituximab may be a better treatment for CLL or SLL.

Study Details

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 11, 2009
Enrollment StartJun 1, 2009
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 17.1 years ago

Interventions

Fludarabine Phosphatedrug

Given IV

Cyclophosphamidedrug

Given IV

Rituximabbiological

Given IV

Vorinostatdrug

Given PO