EWALL-PH OBSERVARTORY 2022 | NCT07684131

Studies
EWALL-PH OBSERVARTORY 2022

NCT07684131

Sponsor

Versailles Hospital

Status

Recruiting

Last Update Posted

Jul 6, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Acute Lymphoblastic Leukemia

Interventions

Not provided

Countries

France

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

Official Title

AN OBSERVATORY FOR PATIENTS AGED 18 YEARS AND OVER WITH PHILADELPHIA CHROMOSOME POSITIVE (PH+ OR BCR::ABL1+) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) AND TREATED WITH THE COMBINATION OF BCR::ABL1 INHIBITORS AND CHEMOTHERAPY AND/OR CORTICOSTEROIDS AND/OR A MONOCLONAL ANTIBODY.

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2024Actual

Primary Completion Date

Jun 15, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Apr 4, 2026

First Submission Date that Met QC Criteria

Jul 1, 2026

First Posted Date

Jul 6, 2026Actual

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

Jul 1, 2026

Last Update Posted Date

Jul 6, 2026Actual

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

An observatory for patients aged 18 years and over with Philadelphia chromosome positive (Ph+ or BCR::ABL1) acute lymphoblastic leukemia (ALL) and treated with the combination of BCR::ABL1 inhibitors and chemotherapy and/or corticosteroids and/or a monoclonal antibody.

Detailed Description

Not provided

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

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival by 12 months		12 months

Secondary Outcomes

Measure	Description	Time Frame
overal survival by 36 months		36 months
proportion of complete remission		36 months
the molecular response defined by BCR//ABL1/ABL1 ratio in bone marrow and/or peripheral blood

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients ≥ 18 years
Philadelphia chromosome or BCR::ABL1 positive acute lymphoblastic leukaemia
Treatment with the combination of BCR::ABL1 inhibitors and chemotherapy and/or corticotherapy and/or a monoclonal antibody

Exclusion Criteria:

Patients deceded and having previously refused data collection
Not included in a prospective clinical trial

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

Acute Lmphoblastic Leukaemia with Philadelphia chromosome or BCR::ABL1 positive

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sandrine Roux	Contact	+33139239777		sroux@ght78sud.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe hospitalier sud	Not yet recruiting	Amiens			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

Not provided