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Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL

NCT03593018 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-04-23

No results posted yet for this study

Summary

This study evaluates the efficacy of Oral azacitidine versus single-agent Investigator's Choice Therapy in patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.

Conditions

  • Relapsed Angioimmunoblastic T-Cell Lymphoma
  • Refractory Angioimmunoblastic T-cell Lymphoma

Interventions

DRUG

Oral azacitidine

Azacitidine tablets

DRUG

Romidepsin

Romidepsin injection

DRUG

Bendamustine

Bendamustine injection

DRUG

Gemcitabine

Gemcitabine injection

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Jehan DUPUIS, MD · Henri Mondor University Hospital

  • François LEMONNIER, MD · Henri Mondor University Hospital

  • Kunihiro TSUKASAKI, MD · Saitama Medical University International Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2021-02-10
Completion
2025-08-28

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03593018 on ClinicalTrials.gov