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CYT-0851 for Cancer
Study Summary
This trial is testing a new cancer drug to see if it is safe and works well.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My cancer is a type of B cell malignancy confirmed by testing.I can and agree to have a biopsy, or I can provide a recent sample if needed.I have not had a heart attack or stroke in the last 6 months.I haven't had cancer treatment in the last 14 days.I had hepatitis C but completed treatment and now have an undetectable viral load.My recent tests show positive biomarkers.I cannot eat two full meals a day or swallow pills.My high blood pressure is not under control.I have a second cancer but it's either skin cancer treated successfully, localized prostate cancer, or any cancer that's been stable or in remission without treatment for 2 years.I am a male who agrees to use contraception and not donate sperm during and for 90 days after the study.I have active cancer spread to my brain or spinal cord.I have ongoing lung inflammation.My cancer is confirmed by lab tests and meets certain criteria.I have serious vision problems due to cataracts.Your disease can be measured and tracked using specific criteria for that disease.I have been diagnosed with HIV.I have hepatitis B but my viral load is undetectable without medication.I have severe nerve pain or damage.You have severe memory loss or major changes in your thinking abilities.I have not been in a clinical trial or taken any experimental drugs in the last 14 days.My spinal cord compression hasn't been treated or wasn't stable for 2 weeks before my screening.Your heart's electrical activity, called the QTc interval, is longer than 450 milliseconds for males or 470 milliseconds for females.My cancer has spread to the lining of my brain or spinal cord.I have received WBC growth factors in the last 14 days.Your test results are lower than the levels specified for the study.I am on a daily steroid treatment not for cancer, equivalent to more than 10mg of Prednisone.I need fluid removed from my abdomen more often than every 4 weeks.I am fully active or can carry out light work.I have a history of lung scarring or fibrosis.I had a bowel blockage treated medically within the last month.I am 18 years old or older.I am not pregnant, breastfeeding, and have a recent negative pregnancy test.I have had a stem cell transplant from a donor.I have lost more than 10% of my weight in the last 3 months.I am currently on medication for an infection.I cannot commit to all the study visits.I do not have any severe illnesses that would make this study too risky for me.I am on specific medications that require careful monitoring.I am taking medication that can affect my heart's rhythm.
- Group 1: CYT-0851 dose escalation
- Group 2: CYT-0851 and capecitabine
- Group 3: CYT-0851 dose expansion
- Group 4: CYT-0851 and rituximab and bendamustine
- Group 5: CYT-0851 and gemcitabine
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are new patients being enrolled in this clinical trial?
"From what is published on clinicaltrials.gov, it appears that this particular trial is open and looking for volunteers. The listing was created on October 9th, 2019 with the most recent update being from August 24th, 2020."
What are the primary health concerns that CYT-0851 has been shown to improve?
"CYT-0851 is an effective treatment for diffuse large B-cell lymphoma (DLBCL), hodgkin disease, and other b-cell lymphomas."
What goals does this research hope to achieve?
"The purpose of this 24 month long experiment is to study the incidence of dose limiting toxicity. Additionally, data will be collected on laboratory and ECG abnormalities, duration of response, and objective response rate."
How many different places are conducting this research currently?
"There are 18 locations in total where this trial is recruiting patients, these include the University of Michigan in Ann Arbor, Michigan, John Theurer Cancer Center at HUMC in Hackensack, New jersey and Oklahoma University-Stephenson Cancer Center in Oklahoma City, Oklahoma."
How many individuals are currently taking part in this research project?
"A total of 320 individuals are required for this clinical trial, and these participants must meet the pre-specified inclusion criteria. The trial locations include University of Michigan in Ann Arbor, Michigan and John Theurer Cancer Center at HUMC in Hackensack, New jersey."
Is this the first time CYT-0851 is being trialed?
"CYT-0851 was first studied at National Institutes of Health Clinical Center in 1993. There have been 874 completed studies thus far, with 460 clinical trials still active. A large number of these trials are based out Ann Arbor, Michigan."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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