CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Dasatinibdrug
Likely dose
Dasatinib orally once dailyAI-extracted
Key inclusion· 5
  • Age 18 years or older
  • CLL/SLL confirmed by flow cytometry positive for CD19, CD23, and CD5 (CD23 may be negative if cyclin D1 negative)
  • Failed at least 1 fludarabine-containing regimen OR at least 2 non-fludarabine-containing regimens OR has contraindication to fludarabine
  • ECOG performance status 0-2
Key exclusion· 9
  • Pregnant or breast-feeding women
  • Uncontrolled angina within 3 months
  • Diagnosed or suspected congenital long QT syndrome
  • History of clinically significant ventricular arrhythmias

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

Search/NCT00438854
NCT00438854Phase 2Completed

Phase II Study of Dasatinib (BMS-354825) in Relapsed Chronic Lymphocytic Leukemia

Massachusetts General Hospital·interventional·Posted Feb 22, 2007·Updated Dec 13, 2017

In Brief

A Phase 2 clinical trial evaluating Dasatinib for Chronic Lymphocytic Leukemia. Completed, enrolled 15 participants across 2 sites.

Detailed Summary

The purpose of this research study is to see if Dasatinib is effective and safe to give to people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the drug on LYN kinase activity in blood and bone marrow. Recent research shows that a key enzyme in CLL cells is responsible for cell survival. This enzyme is called LYN kinase. Laboratory studies show that inhibition of LYN kinase in CLL cells results in the death to CLL cells. Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on CLL cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2007
Enrollment StartDec 1, 2006
Primary CompletionOct 1, 2010
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 19.4 years ago

Interventions

Dasatinibdrug

Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.