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Hypomethylation Agent

Nivolumab + ASTX727 for B-Cell Lymphoma

Phase 1
Recruiting
Led By Catherine S Diefenbach
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
Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status =< 2 (Karnofsky >= 80%)
Dose Escalation: Histologically confirmed relapsed or refractory B cell lymphoma (non-Hodgkin lymphoma [NHL] or Hodgkin lymphoma [HL])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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

Who is the study for?
Adults with relapsed or refractory B-cell lymphoma, including DLBCL, who have tried at least one other treatment and are not eligible for a transplant. They must be in relatively good health (ECOG/Karnofsky >=80%), have certain blood cell counts, no severe liver or kidney issues, and no uncontrolled illnesses. HIV-positive patients on effective therapy can join; those with hepatitis must be treated. Participants must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dosage of Nivolumab combined with ASTX727 (Decitabine and Cedazuridine) for B-cell lymphoma that's returned or hasn't responded to treatment. The goal is to see if this combo can help the immune system fight cancer better by stopping tumor growth.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from receiving drugs through a vein, fatigue, digestive problems like stomach pain or constipation, changes in blood cells leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly self-sufficient and can carry out daily activities.
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My B cell lymphoma has come back or did not respond to treatment.
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My white blood cell count is at least 1,000, unless my bone marrow is affected.
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My DLBCL has returned or did not respond to treatment.
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My hepatitis B virus is undetectable with treatment.
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I have DLBCL, failed first chemotherapy, can't have a transplant, and may have tried stem cell or CAR-T therapy.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I am not on high-dose steroids or other immune-weakening medicines.
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My heart condition does not severely limit my daily activities.
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My DLBCL has returned or did not respond to treatment.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I have HL or B cell NHL, failed 2 treatments, and can't or won't do a stem cell transplant.
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I am 18 years old or older.
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I am mostly self-sufficient and can carry out daily activities.
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My B cell lymphoma has come back or did not respond to treatment.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Complete response rate
Duration of response
Overall response rate
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, decitabine and cedazuridine)Experimental Treatment5 Interventions
Patients receive decitabine and cedazuridine PO QD on days 1-3 or 1-5 of each cycle and nivolumab IV over 30 minutes on day 15 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2260
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,320 Total Patients Enrolled
Catherine S DiefenbachPrincipal InvestigatorLaura and Isaac Perlmutter Cancer Center at NYU Langone
3 Previous Clinical Trials
233 Total Patients Enrolled

Media Library

Decitabine and Cedazuridine (Hypomethylation Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05272384 — Phase 1
Hodgkin's Lymphoma Research Study Groups: Treatment (nivolumab, decitabine and cedazuridine)
Hodgkin's Lymphoma Clinical Trial 2023: Decitabine and Cedazuridine Highlights & Side Effects. Trial Name: NCT05272384 — Phase 1
Decitabine and Cedazuridine (Hypomethylation Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05272384 — Phase 1

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 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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~18 spots leftby Jun 2027