Decitabine and Cedazuridine for Non-Hodgkin Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Hodgkin Lymphoma+5 MoreDecitabine and Cedazuridine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Eligible Conditions
  • Non-Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Refractory Hodgkin Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Diffuse Large B Cell Lymphoma (DLBCL)

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Complete response rate
Duration of response
Incidence of adverse events
Overall response rate
Overall survival
Partial response rate
Progression survival

Trial Safety

Trial Design

1 Treatment Group

Treatment (nivolumab, decitabine and cedazuridine)
1 of 1

Experimental Treatment

27 Total Participants · 1 Treatment Group

Primary Treatment: Decitabine and Cedazuridine · No Placebo Group · Phase 1

Treatment (nivolumab, decitabine and cedazuridine)Experimental Group · 5 Interventions: Positron Emission Tomography, Biospecimen Collection, Computed Tomography, Nivolumab, Decitabine and Cedazuridine · Intervention Types: Procedure, Procedure, Procedure, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2820
Biospecimen Collection
2004
Completed Phase 1
~670
Computed Tomography
2017
Completed Phase 2
~3410
Nivolumab
2014
Completed Phase 3
~5260

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,098 Previous Clinical Trials
41,145,750 Total Patients Enrolled
Catherine S DiefenbachPrincipal InvestigatorLaura and Isaac Perlmutter Cancer Center at NYU Langone
3 Previous Clinical Trials
233 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with DLBCL must have failed at least first line chemotherapy and must be transplant ineligible (either secondary to performance status or lack of adequate disease control or patient preference).
Patients must have histologically confirmed relapsed or refractory DLBCL.
You have a neutrophil count of at least 1,000/mcL.
You have an elevated white blood cell count (leukocytes).