Open-Label Study to Evaluate CC-486 Long-term Safety in Subjects with Hematological Disorders

• Research type

  Research Study

• Full title

  A Phase 2, Open-label, Single-arm Rollover Study to Evaluate Long-term Safety in Subjects Who Participated in Other Celgene Sponsored CC-486 (oral azacitidine) Clinical Trials in Hematological Disorders.

• IRAS ID

  1008135

• Contact name

  Joana Stevens

• Contact email

  UKStart-upteam.SM@ppd.com

• Sponsor organisation

  PPD Global Ltd

• Eudract number

  2023-503272-25

• Clinicaltrials.gov Identifier

  NCT02494258

• Research summary

  Study to allow continuation of treatment with Azacitidine for patients with blood disorders who previously participated in a clinical trial with this same treatment or substance.

  CC-486-GEN-001 is a Phase 2, open-label, single-arm, rollover study that will evaluate the longterm safety in subjects who participate in other oral azacitidine Celgene sponsored clinical trials for hematological disorders. In particular, ongoing patient from AZA-MDS-003 study (A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Compare Efficacy and Safety of Oral Azacitidine Versus Placebo Plus Best Supportive Care in Subjects with RBC Transfusion-Dependent Anemia and Thrombocytopenia Due to IPSS Lower Risk MDS (EudraCT Number: 2012-002471-34)) will be able to roll over in this CC-486-GEN-001 study.

  All subjects participating in a Celgene CC-486 sponsored study whether on active CC-486 or placebo, and as described in Section 4 of this protocol may participate in this study.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  23/LO/0552

• Date of REC Opinion

  11 Oct 2023

• REC opinion

  Further Information Favourable Opinion