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Nivolumab + ASTX727 for B-Cell Lymphoma
Study Summary
This trial is testing a new immunotherapy treatment for people with B-cell lymphoma that has come back or does not respond to other treatments. The new treatment consists of two drugs, nivolumab and ASTX727. Nivolumab is a monoclonal antibody that helps the body's immune system attack the cancer. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Decitabine is a hypomethylation agent that helps the bone marrow produce normal blood cells. Cedazuridine is a cytidine deaminase inhibitor that prevents the breakdown of
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?
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- My brain scans show no worsening after treatment for brain metastases.I am mostly self-sufficient and can carry out daily activities.I am not pregnant or breastfeeding.Your platelet count should be at least 75,000/mcL, unless you have bone marrow involvement, in which case lower values may be allowed.I can understand and am willing to sign the consent form, or I have someone who can do it for me.My B cell lymphoma has come back or did not respond to treatment.My white blood cell count is at least 1,000, unless my bone marrow is affected.My DLBCL has returned or did not respond to treatment.My doctor says I don't need immediate brain treatment for my cancer.I have HL or B cell NHL, failed 2 treatments, and can't be cured by other means. I'm also either resistant or allergic to brentuximab vedotin, and have considered ASCT.The amount of bilirubin in your body is within the normal range.You cannot be taking any experimental drugs at the same time.My hepatitis B virus is undetectable with treatment.I had cancer before, but it's been in remission or treated over 3 years ago, except for skin cancer or localized cancer.I have DLBCL, failed first chemotherapy, can't have a transplant, and may have tried stem cell or CAR-T therapy.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I have DLBCL, failed first chemotherapy, can't have a transplant, and may have tried stem cell or CAR-T therapy.My white blood cell count is at least 1,000, unless my bone marrow is affected.I have recovered from side effects of previous cancer treatments, except for hair loss.I do not have cancer spread to my brain or its coverings.I have been checked for serious gut issues before joining the study.I am not on high-dose steroids or other immune-weakening medicines.My heart condition does not severely limit my daily activities.I am a woman who can still have children, not sterilized, and not in menopause.I will use contraception for the required time after my last dose.I was taken off anti-PD-1/PD-L1 or anti CTLA4 treatments due to side effects.I agree to use effective birth control during and after the study.I do not have an active or history of severe autoimmune disease that could worsen.You have had allergic reactions to drugs with similar chemical or biological makeup as ASTX727 or nivolumab, including severe reactions to monoclonal antibodies.You must have a certain level of white blood cells in your blood, unless there is a documented bone marrow issue.My DLBCL has returned or did not respond to treatment.My kidney function, measured by creatinine levels or clearance, is within the required range.I am HIV-positive, on treatment, and my viral load is undetectable.I have HL or B cell NHL, failed 2 treatments, and can't or won't do a stem cell transplant.I am 18 years old or older.I am mostly self-sufficient and can carry out daily activities.I haven't had chemotherapy or major radiation in the last 4-6 weeks, but may have had small-area radiation if it didn't target a main cancer spot and no new bone metastases were found.My B cell lymphoma has come back or did not respond to treatment.I am 18 years old or older.
- Group 1: Treatment (nivolumab, decitabine and cedazuridine)
- 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
What is the current number of participants enrolled in this experiment?
"Indeed, clinicaltrials.gov confirms that this medical experiment is seeking participants. The trial was initially published on June 30th 2022 and has since been amended on November 25th of the same year. A total of 27 patients must be enrolled across two centers for the study to move forward."
To what extent is Decitabine and Cedazuridine a threat to human health?
"Considering the limited evidence of its safety and efficacy, Decitabine and Cedazuridine were rated a 1 on our scale out of 3."
Are patients still being enrolled in this research venture?
"Correct. According to the clinicaltrials.gov registry, this medical trial is actively welcoming volunteers which was posted on June 30th 2022 and recently updated on November 25th of that same year. 27 individuals are needed from 2 sites in order to complete the research project."
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