Completed

A Phase 2 Study of Oral Enzastaurin HCl in Patients With Relapsed Mantle Cell Lymphoma

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What is being tested

enzastaurin

Drug
Who is being recruted

Hemic and Lymphatic Diseases+7

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: July 1, 2020
Sourced from a government-validated database.Claim as a partner

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.

NCT00088205
Principal SponsorEli Lilly and Company
Last updated: July 1, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, Mantle-Cell

Criteria

5 inclusion criteria required to participate
Adequate organ function

Have discontinued all previous therapies for cancer, except corticosteroids up to 25 milligrams per day (mg/day)

Mantle cell lymphoma

Previous treatment for mantle cell lymphoma

Show More Criteria

2 exclusion criteria prevent from participating
Inability to swallow tablets

Must not have significant heart problems

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study 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 Maps

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

Parkville, Australia

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

Prahran, Australia

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

Wodonga, Australia
Completed17 Study Centers