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Anti-tumor antibiotic

Azacitidine + Chemotherapy for Lymphoma

Phase 1

Waitlist Available

Led By Brian Hess, MD

Research Sponsored by Medical University of South Carolina

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 from start of treatment to time of documented progression or date of death, whichever occurs first, assessed up to 1 year.

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat leukemia, to see if it is safe and if it improves patient outcomes.

Who is the study for?

This trial is for adults with relapsed/refractory Diffuse Large B Cell Lymphoma who've had prior anti-CD20 chemo and are eligible for stem cell transplant. They must have measurable disease, good organ function, no uncontrolled infections or recent strokes, not be pregnant/breastfeeding, and agree to use effective birth control.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of adding oral azacitidine to R-ICE chemotherapy in treating lymphoma. It aims to see if this combination improves patient outcomes compared to standard treatment protocols.See study design

What are the potential side effects?

Potential side effects may include nausea, vomiting, low blood counts leading to increased infection risk or bleeding problems, liver issues reflected by abnormal blood tests, fatigue from anemia or general drug effects on energy levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment to time of documented progression or date of death, whichever occurs first, assessed up to 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment to time of documented progression or date of death, whichever occurs first, assessed up to 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to time of documented progression or date of death, whichever occurs first, assessed up to 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Azacitidine

Secondary outcome measures

Adequate peripheral stem cell collection

Response rate

progression free survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oral azacitidine + R-ICEExperimental Treatment2 Interventions

Patients will receive 7 days of oral azacitidine (CC-486) leading into cycle 1 day 1 of R-ICE chemotherapy. R-ICE chemotherapy may be administered as an inpatient or as an outpatient . Oral azacitidine will be administered on days 8-21 of cycles 1 and cycle 2. R-ICE will be administered per standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

R-ICE

2019

Completed Phase 1

~10

Oral azacitidine

2012

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Celgene CorporationIndustry Sponsor

444 Previous Clinical Trials

58,227 Total Patients Enrolled

Medical University of South CarolinaLead Sponsor

937 Previous Clinical Trials

7,396,841 Total Patients Enrolled

Brian Hess, MDPrincipal InvestigatorMedical University of South Carolina

Media Library

R-ICE (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03450343 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Oral azacitidine + R-ICE

Non-Hodgkin's Lymphoma Clinical Trial 2023: R-ICE Highlights & Side Effects. Trial Name: NCT03450343 — Phase 1

R-ICE (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03450343 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you explain what maladies are usually addressed by R-ICE?

"R-ICE is a viable treatment for malignancies, blasts in the 20-30% range, and neutropenia or thrombocytopenia."

Answered by AI

Are there any vacancies available for participants in this clinical research?

"According to clinicaltrials.gov, this particular trial has concluded its patient search at this time. The original posting was made on April 4th 2019 and the last update occurred on August 9th 2022. At present, there are 1,957 other studies that are currently seeking volunteers in different locations around the world."

Answered by AI

Has the Food and Drug Administration given clearance to R-ICE?

"Our team's assessment ranks the safety of R-ICE at 1 as it is a Phase 1 trial, meaning there exists only minimal evidence confirming its efficacy and security."

Answered by AI

Are there any other experimental investigations that have implemented the R-ICE protocol?

"At present, there are 174 running trials for R-ICE with 32 of them being in the final phase. While Saint Louis, Missouri is home to most studies, 5671 clinical sites globally are hosting research on this medicinal intervention."

Answered by AI

To what extent has recruitment for this experiment been successful?

"Unfortunately, the recruitment process for this medical trial has already been concluded. The study was initially posted on April 4th 2019 and last updated August 9th 2022; however, if you are still looking to participate in a clinical trial there are 1783 studies involving B-lymphocytes as well as 174 R-ICE trials actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral Azacitidine Plus Salvage Chemotherapy in Relapsed/Refractory Diffuse Large B Cell Lymphoma

2019. "Oral Azacitidine Plus Salvage Chemotherapy in Relapsed/Refractory Diffuse Large B Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03450343.