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Monoclonal Antibodies
Anti-ICOS Monoclonal Antibody for Peripheral T-cell Lymphoma
Phase 1
Waitlist Available
Led By Julio C Chavez
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to dose on day 1, immediately after dose, and at 6 minutes, 24, 48 and 72 hours post dose of cycle 1 and cycle 2, and then on day 1 pre-dose of every subsequent cycle
Awards & highlights
Study Summary
This trial is testing a monoclonal antibody that may help the body's immune system fight cancer cells in patients with relapsed or refractory T-cell lymphoma.
Who is the study for?
This trial is for patients with certain types of T-cell lymphoma that have not improved or returned after treatment. Eligible participants must have a specific diagnosis, acceptable organ function tests, measurable disease, and an ECOG performance status of 2 or less. They should not be pregnant or breastfeeding and must agree to use contraception. People with severe allergies to similar drugs, active infections like tuberculosis, recent major surgery, uncontrolled illnesses, HIV infection or those who've had certain vaccines recently cannot join.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dosage of MEDI-570 in patients with relapsed/refractory peripheral T-cell lymphoma follicular variant or angioimmunoblastic T-cell lymphoma. MEDI-570 is a monoclonal antibody designed to modify the immune system's response and potentially inhibit tumor growth.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs which could lead to symptoms affecting different parts of the body depending on which organs are involved. Specific side effects will be monitored due to MEDI-570's novel action on the immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to dose on day 1, immediately after dose, and at 6 minutes, 24, 48 and 72 hours post dose of cycle 1 and cycle 2, and then on day 1 pre-dose of every subsequent cycle
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to dose on day 1, immediately after dose, and at 6 minutes, 24, 48 and 72 hours post dose of cycle 1 and cycle 2, and then on day 1 pre-dose of every subsequent cycle
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicity and safety of anti-inducible T-cell co-stimulator (ICOS) monoclonal antibody MEDI-570
Maximum tolerated dose (MTD) of anti-inducible T-cell co-stimulator (ICOS) monoclonal antibody MEDI-570
Recommended phase 2 dose of anti-inducible T-cell co-stimulator (ICOS) monoclonal antibody MEDI-570
Secondary outcome measures
Immunogenicity
Overall response rate
Overall survival (OS)
+2 moreOther outcome measures
Biomarkers of response and resistance to anti-inducible T-cell co-stimulator (ICOS) monoclonal antibody MEDI-570
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (MEDI-570)Experimental Treatment3 Interventions
Patients receive anti-ICOS monoclonal antibody MEDI-570 IV over 1-4 hours on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,132 Total Patients Enrolled
Julio C ChavezPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is listed as eligible for the trial.If you have asthma or mild seasonal allergies that are well-controlled, you can still participate.I haven't had serious infections like TB or severe herpes in the last 6 months.You have a history of a weakened immune system from birth.My condition worsened or didn't improve after a stem cell transplant.I had a stem cell transplant using my own cells within the last 3 months.You are not currently taking any other experimental medications.I have HIV, which may affect my eligibility due to risks with MEDI-570.You have had allergic reactions in the past to similar medicines or biological substances like MEDI-570.I do not have brain metastases.I have not received a live vaccine in the last 12 weeks.I have been tested for TB and do not have it.I'm sorry, but it seems like you didn't provide the full criterion. Could you please provide more details or the complete criterion?I do not have active hepatitis B or C, or if I do, it's under control with no liver damage.I have had a stem cell transplant from a donor.I have not had major surgery in the last 30 days or during the study.I am not pregnant or breastfeeding.I finished my last cancer treatment at least 14 days ago and have recovered from its side effects.My PTCL or AITL cancer did not respond to at least one treatment.I have advanced CTCL that has not improved after treatment, but I don't have ACLCL or lymphomatoid papulosis.My condition is follicular lymphoma grade 1, 2, or 3A.I have a tumor that can be measured by CT, MRI, or physical exam.You are expected to live for at least 6 more months.I haven't had a blood transfusion in the last 2 weeks.My bone marrow meets the trial's minimum health standards.My kidney function is good based on my creatinine clearance rate.I can provide tissue samples for the study, either from previous surgeries or a new biopsy.I have an underactive thyroid caused by an autoimmune condition.I have vitiligo.My diagnosis is listed among the specified conditions.I have PTCL or AITL that hasn't responded to at least one treatment. ALCL and NKTCL are not my diagnoses.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have Type 1 diabetes.I can take care of myself but might not be able to do heavy physical work.My condition did not improve after two different treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (MEDI-570)
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.
What is the current extent of this research experiment?
"This research study is being conducted across numerous sites, including Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center in Houston, Texas, BCCA-Vancouver Cancer Centre in Vancouver, British Columbia and Washington University School of Medicine in Saint Louis Missouri. In total there are 23 recruitment centres for this trial."
Answered by AI
What is the ultimate ambition of this experiment?
"The primary purpose of this trial, evaluated over a 21 day time frame, is to assess the maximum tolerated dose (MTD) of MEDI-570 through anti-inducible T-cell co-stimulation. Secondary objectives are pharmacokinetic investigations including plasma concentration and related parameters; progression free survival data collected through descriptive statistics or logistic regression when appropriate; and overall response rate as per Revised Response Criteria for Malignant Lymphoma in the Lugano Classification."
Answered by AI
To what extent might Anti-ICOS Monoclonal Antibody MEDI-570 be detrimental to patients?
"Due to a lack of both safety and efficacy data, Anti-ICOS Monoclonal Antibody MEDI-570 was given a score of 1 on the risk assessment scale."
Answered by AI
Is there space available for participants in this trial?
"Clinicaltrials.gov does not list this medical trial as actively recruiting patients, with initial posting on April 22nd 2016 and the most recent update occurring on July 16th 2022. However, there are still 2689 other trials that require participants at present."
Answered by AI
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