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

NCT03450343 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-10-28

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and tolerability of adding oral azacitidine to the chemotherapy combination R-ICE. This study will also look at whether or not disease outcomes improve with the combination.

Conditions

  • Large B-Cell Diffuse Lymphoma

Interventions

DRUG

Oral azacitidine

Azacitidine can be taken with or without food at the same time every day.

DRUG

R-ICE

R-ICE is approved for the treatment of NHL before ASCT for relapsed or primary refractory diffuse large b-cell lymphoma. R-ICE consists of rituximab, etoposide, carboplatin and ifosfamide. R-ICE will be administered per institutional guidelines.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Brian Hess, MD · Medical University of South Carolina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2023-08-31
Completion
2024-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03450343 on ClinicalTrials.gov