NCT03869502

Brief Summary

Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
4 countries

9 active sites

Status
unknown

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

Study Start

First participant enrolled

October 25, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

5.7 years

First QC Date

March 7, 2019

Last Update Submit

May 9, 2023

Conditions

Chronic Myeloid Leukemia in Myeloid Blast Crisis

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    how many patients survive after a blast crisis event

    through study completion in 2024

Secondary Outcomes (3)

  • Rate of hematologic response to treatment

    through study completion in 2024

  • Rate of molecular response to treatment

    through study completion in 2024

  • Rate of blast crises in Europe in the era of TKI treatment

    through study completion in 2024

Eligibility Criteria

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

Patients with CML Blast crisis, either newly diagnosed or as evolution of a CML in chronic phase

You may qualify if:

  • Age \>18 years
  • Diagnosis of BCR-ABL positive CML blast crisis according to the WHO criteria:
  • Blasts 20% or more of peripheral blood white cells or bone marrow cells or
  • Extramedullary blast proliferation or
  • Large foci or clusters of blasts in bone marrow biopsy

You may not qualify if:

  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Masaryk University Hospital Brno

Brno, 62500, Czechia

RECRUITING

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Essen

Essen, 45147, Germany

RECRUITING

University Hospital Jena

Jena, 07747, Germany

RECRUITING

Universitätsklinikum Leipzig AöR

Leipzig, 04103, Germany

RECRUITING

Universitätsmedizin Mannheim

Mannheim, 68169, Germany

RECRUITING

Universitaetsklinikum Muenster

Münster, 48149, Germany

RECRUITING

I. P. Pavlov First St. Petersburg State Medical University

Saint Petersburg, 197022, Russia

RECRUITING

National Research Center for Radiation Medicine

Kiev, 02000, Ukraine

RECRUITING

Study Officials

  • Annamaria Brioli, PhD MD

    Univerity of Jena

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annamaria Brioli, PhD MD

CONTACT

+49 36419324576blastcrisis@med.uni-jena.de

Christian Fabisch, Dr.

CONTACT

+49 36419396670blastcrisis@med.uni-jena.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 11, 2019

Study Start

October 25, 2018

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

A joint publication is planned. But no data of trial Centers will be shared with the other trial centers.

Locations

UA(1)CZ(1)DE(6)RU(1)