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2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients

NCT02917720 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-09-22

No results posted yet for this study

Summary

The main goal of the study is the assessment of duration of major molecular response (MMR) or better at 12 and 36 months after stopping tyrosine kinase inhibitors (TKI) therapy a second or third time in patients with at least three years prior TKI treatment comprising at least two years of nilotinib treatment within this trial and maintained stable MR4 (BCR-ABL ratio \<0,01% on international Scale (IS) for at least one year and MR4.5 (BCR-ABL ratio \<0,0032% on IS) for at least 6 months:

* who failed a first stop in the EURO-SKI study (standardized criteria)
* who failed a first or second stop outside the EURO-SKI study but would have had fulfilled same eligible criteria and were stopped according to EURO-SKI rules
* who failed a first or second stop outside the EURO-SKI study without fulfilling EURO-SKI rules

Conditions

  • Chronic Myeloid Leukemia

Interventions

OTHER

TKI discontinuation

2nd or 3rd TKI stop after pre-treatment with nilotinib.

DRUG

nilotinib

Pre-treatment with nilotinib 300 mg/bid for 2 years

Sponsors & Collaborators

  • Heidelberg University

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • European LeukemiaNet

    lead NETWORK

Principal Investigators

  • Susanne Geiselhart · Heidelberg University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2026-09-30
Completion
2027-09-30

Countries

  • Germany
  • Netherlands

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 NCT02917720 on ClinicalTrials.gov