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ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission

NCT03117816 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2023-03-31

No results posted yet for this study

Summary

A randomized, open-label assessor blinded, multi-center, controlled phase III Trial to evaluate the efficacy of AOP2014 administered bi-weekly subcutaneously (s.c.) in preventing molecular relapse (loss of MMR) in CML patients, who discontinue ABL tyrosine kinase inhibitor therapy (TKI) in deep molecular remission of MR4 or better (MR4.5, or MR5).

Conditions

  • Chronic Myeloid Leukemia in Remission

Interventions

DRUG

AOP2014 / Pegylated-Proline-interferon alpha-2b

AOP2014 as pre-filled auto-injection pen for subcutaneous injection, containing 250 µg AOP2014 / 0.5 ml. The solution also contains inactive ingredients (sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, and acetic acid). The solution is colorless to light yellow.

OTHER

Surveillance

For patients randomized into this treatment arm stopp their standard treatment and will just be under observation.

Sponsors & Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

    collaborator OTHER

  • AOP Orphan Pharmaceuticals AG

    collaborator INDUSTRY

  • Philipps University Marburg

    lead OTHER

Principal Investigators

  • Andreas Burchert, Prof. Dr. · Philipps University Marburg

  • Franck E Nicoloni, MD, PhD · Centre Léon Bérard, Lyon

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-04
Primary Completion
2022-01-26
Completion
2022-12-12

Countries

  • France
  • Germany

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 NCT03117816 on ClinicalTrials.gov