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ORACLE - Randomized Phase 3 Study evaluating the Efficacy and the Safety of Oral Azacitidine (CC-486) compared to Investigator’s Choice Therapy in Patient with Relapsed or Refractory Angioimmunoblastic T cell Lymphoma

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519336-16-00
Enrollment
2
Registered
2024-12-05
Start date
2018-10-31
Completion date
2025-08-28
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or Refractory Angioimmunoblastic T cell Lymphoma

Brief summary

Progression free survival (PFS)

Detailed description

Overall Survival (OS)

Interventions

DRUGBENDAMUSTINE HYDROCHLORIDE
DRUGAZACITIDINE
DRUGGEMCITABINE

Sponsors

LYSARC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression free survival (PFS)

Secondary

MeasureTime frame
Overall Survival (OS)

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026