European CML Blast Crisis Register | NCT03869502

Studies
European CML Blast Crisis Register

NCT03869502

Sponsor

University of Jena

Status

Unknown status

Last Update Posted

May 10, 2023Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Chronic Myeloid Leukemia in Myeloid Blast Crisis

Interventions

Not provided

Countries

Czechia
Germany
Russia
Ukraine

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 25, 2018Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Mar 7, 2019

First Submission Date that Met QC Criteria

Mar 8, 2019

First Posted Date

Mar 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2023

Last Update Posted Date

May 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Since the advent of treatment with tyrosine kinase inhibitors (TKI), the incidence of blast crises has significantly decreased. Nevertheless, about 5% of patients diagnosed with chronic myeloid leukemia (CML) will evolve into a blast phase at some point during the course of their disease. Furthermore, despite the advances made in CML treatment, outcome of patients with blast crises are still dismal. Due to the rarity of this condition clinical trials are challenging, and collaboration between researchers both at national and international level is needed to collect a meaningful number of data.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	how many patients survive after a blast crisis event	through study completion in 2024

Secondary Outcomes

Measure	Description	Time Frame
Rate of hematologic response to treatment	how many patients have a hematologic response to the local standard Treatment after a blast crisis event	through study completion in 2024
Rate of molecular response to treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Lack of informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Annamaria Brioli, PhD MD	Contact	+49 36419324576		blastcrisis@med.uni-jena.de
Christian Fabisch, Dr.	Contact	+49 36419396670		blastcrisis@med.uni-jena.de

Overall Officials

Name	Affiliation	Role
Annamaria Brioli, PhD MD	Univerity of Jena	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Masaryk University Hospital Brno	Recruiting	Brno		62500	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided