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Nilotinib Plus Pegylated Interferon-α2b in CML

NCT01866553 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-10-12

No results posted yet for this study

Summary

The purpose of this trial is to assess the effect of switching CML patients, who have been treated with imatinib ≥ 2 years and who have stable detectable molecular residual disease between 0.01-1.0% (IS), to the combination of Nilotinib and PegIFN, in terms of the proportion of patients who achieve confirmed MR4.0.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Nilotinib

300 mg capsule BID oral use

DRUG

Pegylated interferon α-2b

25 - 40 microgram per week for subcutaneous use

Sponsors & Collaborators

  • Uppsala University Hospital

    collaborator OTHER

  • Novartis

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Jeroen Janssen, MD, PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-04-08
Completion
2016-05-01

Countries

  • Denmark
  • Finland
  • Netherlands
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Companies

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 NCT01866553 on ClinicalTrials.gov