A Phase 2 Study of Oral Enzastaurin HCl in Patients With Relapsed Mantle Cell Lymphoma
enzastaurin
Hemic and Lymphatic Diseases+7
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.This study focuses on a treatment for Mantle Cell Lymphoma, a type of cancer that affects the lymph system. The treatment being tested is a drug called Enzastaurin HCl, which is taken orally. The study aims to understand if this drug is safe for patients who have experienced a relapse of Mantle Cell Lymphoma. It also seeks to identify any potential side effects associated with the drug and evaluate its effectiveness in helping patients manage their condition. During the study, participants will be given Enzastaurin HCl to take orally. The primary outcome measured is the percentage of participants who show 'Freedom From Progression' (FFP) for at least 3 cycles. This means that the participants' condition does not worsen during this period. To determine this, the study uses the Standardized Response Criteria for non-Hodgkin's lymphomas. If a participant shows a 50% increase in the size of their affected lymph nodes or if new affected sites appear, they are considered to have progressive disease. The percentage of FFP is then calculated by dividing the number of participants who are progression-free after 3 cycles of treatment by the total number of treated participants and multiplying the result by 100.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 17 locations
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Woolloongabba, AustraliaOpen For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician in Google MapsFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Parkville, AustraliaFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Prahran, AustraliaFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Wodonga, Australia