NCT03515785

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of ponatinib (Iclusig®) in patients with BCR-ABL positive acute lymphoblastic leukemia (ALL) in standard clinical practice in Europe.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
3 countries

10 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

December 31, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

2.2 years

First QC Date

April 23, 2018

Last Update Submit

December 12, 2018

Conditions

BCR-ABL Positive Acute Lymphoblastic Leukemia

Keywords

acute lymphoblastic leukemiaponatinibtyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

  • Complete hematological remission (CR) rate

    CR defined as leukemic cells not detectable by light microscopy in bone marrow (BM), peripheral blood (PB), or cerebrospinal fluid (CSF) (BM \< 5% blasts).

    6 months

Secondary Outcomes (15)

  • CR rate

    1, 3, 9, and 12 months

  • CR rate

    1, 3, 6, 9, and 12 months

  • Time to CR

    Up to 12 months

  • Minimal residual disease (MRD) level

    3, 6, 9, and 12 months

  • Best MRD (MolR) level rate

    12 months

  • +10 more secondary outcomes

Study Arms (1)

Ph+ ALL Patients

Patients with Ph+ ALL being treated with Iclusig®.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with Ph+ ALL being treated with Iclusig® in Europe.

You may qualify if:

  • Adult patients with BCR-ABL (Ph+) positive ALL who are initiating Iclusig®, or for whom Iclusig® was initiated after January 2015.
  • Patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures.

You may not qualify if:

  • Patients previously treated with investigational ponatinib.
  • Patients who are pregnant and/or breastfeeding.
  • Concurrent treatment with another tyrosine kinase inhibitor for Ph+ALL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ihbt/Úhkt

Prague, 128 00, Czechia

Location

University Hospital Amiens

Amiens, 80080, France

Location

University Hospital Angers

Angers, 49100, France

Location

University Hospital Bordeaux

Bordeaux, 33000, France

Location

University Hospital Grenoble

Grenoble, 38700, France

Location

University Hospital Lyon

Lyon, 69361, France

Location

University Cancer Institute Oncopole

Toulouse, 31059, France

Location

University Hospital Halle/Saale

Halle, 06120, Germany

Location

University Hospital Munich

Munich, 81377, Germany

Location

University Hospital Rostock

Rostock, 18057, Germany

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Dieter Hoelzer, Prof. Dr. med.

    Oncologikum Frankfurt

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 4, 2018

Study Start

December 31, 2018

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

December 14, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)FR(6)CZ(1)