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Monoclonal Antibodies
Epratuzumab for Non-Hodgkin's Lymphoma
Phase 3
Waitlist Available
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 and over
Performance status: Karnofsky 60-100% or ECOG 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test the effectiveness of epratuzumab in treating low-grade non-Hodgkin's lymphoma that has not responded to chemotherapy or rituximab.
Who is the study for?
This trial is for adults with low-grade follicular B-cell non-Hodgkin's lymphoma that hasn't improved after chemotherapy or rituximab. Participants must have a measurable lesion and no bulky disease, serious conditions, other cancers in the past 5 years (except certain skin cancers or cervical carcinoma in situ), or current infections. They should not be pregnant, must test negative for pregnancy, use effective contraception during and post-trial, and have had no more than four prior treatments.Check my eligibility
What is being tested?
The trial is testing epratuzumab's effectiveness on patients with low-grade non-Hodgkin's lymphoma that didn't respond to previous treatments. Epratuzumab is a monoclonal antibody designed to target and kill tumor cells without harming normal cells. This phase III study aims to see if it can help where other therapies haven't.See study design
What are the potential side effects?
Epratuzumab may cause side effects similar to those of other monoclonal antibodies which include allergic reactions at the infusion site, fever, chills, nausea, fatigue, headache, rash and potential harm to normal cells leading to various organ-related symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can care for myself and perform daily activities.
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My liver tests are within the required limits.
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My kidney function is normal or slightly above normal, unless due to my lymphoma.
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My cancer is of the small cleaved or mixed cell type.
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My blood counts meet the required levels and I don't need blood transfusions.
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I have been diagnosed with a type of slow-growing lymphoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,646 Total Patients Enrolled
1,376 Trials studying Lymphoma
381,584 Patients Enrolled for Lymphoma
Jonsson Comprehensive Cancer CenterLead Sponsor
358 Previous Clinical Trials
26,076 Total Patients Enrolled
27 Trials studying Lymphoma
400 Patients Enrolled for Lymphoma
Peter J. Rosen, MDStudy ChairJonsson Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a type of lymphoma that affects the brain.My condition worsened or didn't improve within 6 months after starting rituximab.I have had 4 or fewer previous cancer treatments.It has been over 12 weeks since my last stem cell transplant.I haven't taken corticosteroids in the last 2 weeks.It has been over 4 weeks since I last received radiotherapy on my cancer spot.It has been over 4 weeks since my last major surgery, or I have fully recovered from it.It has been over 4 weeks since I last participated in an experimental therapy.I am 18 years old or older.I have lymphoma and am HIV positive.I have a tumor larger than 10 cm.My condition did not improve after at least one treatment with rituximab.I don't have any serious conditions or infections that would stop me from joining the study.My previous chemotherapy for non-Hodgkin's lymphoma did not work.I will use birth control during and for 3 months after the study.I can care for myself and perform daily activities.My liver tests are within the required limits.My kidney function is normal or slightly above normal, unless due to my lymphoma.I haven't had any cancer in the last 5 years, except for skin cancer or cervical pre-cancer.I am not currently taking steroids.My condition is Richter's lymphoma.It has been over 4 weeks since my last chemotherapy session.My fluid sample from the chest tested positive for lymphoma.I have not had any treatments that combine radiation and antibodies.My cancer is of the small cleaved or mixed cell type.I am not currently taking any experimental treatments or drugs.My blood counts meet the required levels and I don't need blood transfusions.I have been diagnosed with a type of slow-growing lymphoma.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this treatment more harmful than other available options?
"There is some evidence to support the efficacy of this treatment, as it has advanced to a Phase 3 clinical trial. Furthermore, multiple rounds of data have confirmed its safety, so it received a score of 3."
Answered by AI
Are there any vacant positions in this trial for new participants?
"According to the latest information on clinicaltrials.gov, this particular clinical trial is not looking for any more participants. The study was originally posted on 2001-09-01 and was last updated on 2013-12-18. There are, however, 1,782 other clinical trials that are currently seeking candidates."
Answered by AI
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