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Immunosuppressant
Monoclonal Antibodies + Chemotherapy for Non-Hodgkin's Lymphoma
Phase 1
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cardiovascular: LVEF at least 50%
Hepatic: Bilirubin no greater than 1.5 mg/dL, AST no greater than 84 U/L
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will use monoclonal antibodies to attack cancer cells while leaving healthy cells unharmed. The study will also combine this therapy with paclitaxel and cyclosporine to see if it is an effective treatment for patients with non-Hodgkin's lymphoma who have not responded to other treatments.
Who is the study for?
This trial is for adults with non-Hodgkin's lymphoma that hasn't responded to standard treatments. They must have a certain level of blood cells, heart and lung function, no other cancers in the past 5 years, not be pregnant or breastfeeding, and agree to use contraception. People can't join if they've had recent chemotherapy or radiotherapy.Check my eligibility
What is being tested?
The study is testing a combination therapy for non-Hodgkin's lymphoma involving a radiolabeled monoclonal antibody with paclitaxel (a chemotherapy drug) and cyclosporine (an immune system suppressant). It aims to see how effective this mix is at targeting and killing cancer cells.See study design
What are the potential side effects?
Possible side effects include reactions related to the monoclonal antibody such as fever or chills, low blood cell counts from paclitaxel leading to increased infection risk or bleeding problems, and cyclosporine may cause kidney issues or high blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's pumping ability is normal or near normal.
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My liver function tests are within normal limits.
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My non-Hodgkin's lymphoma did not respond to the first round of chemotherapy.
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My lung function tests are within the required range.
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I am mostly able to care for myself and carry out daily activities.
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My lymphoma tissue reacts to Lym-1 in tests.
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I am 18 years old or older.
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My bone marrow biopsy shows less than 25% involvement by NHL.
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My kidney function is good, with creatinine below 1.5 mg/dL or clearance above 50 mL/min.
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?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,583 Total Patients Enrolled
9 Trials studying Lymphoma
765 Patients Enrolled for Lymphoma
Gerald L. DeNardo, MDStudy ChairUniversity of California, Davis
1 Previous Clinical Trials
1 Trials studying Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The study is not suitable for individuals who are expected to live less than 6 months.My heart's pumping ability is normal or near normal.My liver function tests are within normal limits.It has been over 4 weeks since my last chemotherapy session.My non-Hodgkin's lymphoma did not respond to the first round of chemotherapy.My lung function tests are within the required range.It has been over 4 weeks since my last external beam radiotherapy.I haven't had cancer in the last 5 years, am not pregnant or nursing, HIV negative, and use contraception if fertile.My treatment plan for biologic therapy is not decided.I am mostly able to care for myself and carry out daily activities.My lymphoma tissue reacts to Lym-1 in tests.Surgery requirements are not specified for this trial.I am 18 years old or older.My treatment plan does not specify endocrine therapy.My bone marrow biopsy shows less than 25% involvement by NHL.My kidney function is good, with creatinine below 1.5 mg/dL or clearance above 50 mL/min.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there still vacancies for patients to participate in this clinical experiment?
"Based on the clinicaltrials.gov entry for this trial, it appears that recruitment has stopped since its initial post date of March 1st 2001 and last edit from September 19th 2013. However, there are 1750 other studies presently looking to enroll patients."
Answered by AI
To what extent does this therapy pose a hazard to individuals?
"Due to the limited information available on safety and efficacy, this treatment received a score of 1."
Answered by AI
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