Acute Lymphoblastic LeukemiaEwall Obs 2022NCT07684131
EWALL-PH OBSERVARTORY 2022
An observational study of Acute Lymphoblastic Leukemia, run by Versailles Hospital at 23 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 100 participants
- Where
- 23 sitesFrance
- Study dates
- 15 Jan 2024to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute Lmphoblastic Leukaemia with Philadelphia chromosome or BCR::ABL1 positive
Who may be able to join
- 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
Who cannot join
- Patients deceded and having previously refused data collection
- Not included in a prospective clinical trial
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
France23 sites, 23 recruiting
- Not yet recruiting
Groupe hospitalier sud
Amiens
amandine charbonnie, md
- Not yet recruiting
CHU Angers
Angers
aline schmidt, md
- Not yet recruiting
CH de la cote basque
Bayonne
claudie capdupuy, MD
- Recruiting
CHU Bordeaux
Bordeaux
Thibaut Leguay, MD
- Not yet recruiting
Hopital Militaire Percy
Clamart
jean valère Malfuson, MD
- Recruiting
CHU clermont ferrand
Clermont-Ferrand
victoria cacheux, MD
- Recruiting
Centre Hospitalier sud francilien
Corbeil-Essonnes
Stephanie Haiat, MD
- Not yet recruiting
CHU de grenoble
Grenoble
martin carre, md
- Not yet recruiting
CHU Sud Réunion
La Réunion
quentin cabrera, md
- Recruiting
CH Versailles
Le Chesnay
Philippe Rousselot, MD
- Recruiting
CH Le Mans
Le Mans
nathalie denizon, MD
- Not yet recruiting
Chu de Lille
Lille
valérie Coiteux, md
- Not yet recruiting
Hopital de la conception
Marseille
julien colle, md
- Not yet recruiting
Institut Paoli Calmettes
Marseille
Aude Charbonnier, MD
- Not yet recruiting
CHRU de Nancy
Nancy
gabrielle roth guepin, md
- Not yet recruiting
Centre Antoine Lacassagne
Nice, 06189
Lauris Gastaud
- Not yet recruiting
Hopital Cochin
Paris
lise willems, md
- Recruiting
Hopital necker
Paris
felipe suarez, MD
- Recruiting
Hopital St Louis
Paris
emmaunel Raffoux, md
- Not yet recruiting
CH de Lyon
Pierre-Bénite
marie balsat, MD
- Not yet recruiting
CH St Etienne
Saint-Etienne
Emmanuelle Tavernier, md
- Not yet recruiting
ICANS
Strasbourg
karin bilger, MD
- Not yet recruiting
Hopital de Purpan
Toulouse
Francoise huguet, MD
About this study
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.
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.
- Conditions
- Acute Lymphoblastic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival by 12 months
Measured: 12 months
Secondary outcomes (10)
overal survival by 36 months
Measured: 36 months
proportion of complete remission
Measured: 36 months
the molecular response defined by BCR//ABL1/ABL1 ratio in bone marrow and/or peripheral blood
Measured: 36 months
the molecular response defined by IGTR quantification proportion in bone marrow and/or peripheral blood
Measured: 36 months
Event free survival
Measured: 36 months
Relapse free survival
Measured: 36 months
the incidence ofBCR..ABL1 TK mutations
Measured: 36 months
treatment tolerance
Measured: 36 months
Death during induction
Measured: 2 months
Death in complete remission
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start15 Jan 2024
- Primary completion15 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe ROUSSELOT, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684131
- Sponsor's protocol ID
- P22/10_EwallObs 2022
- Acronym
- Ewall Obs 2022
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07684131
- Acronym / sponsor ID
- Ewall Obs 2022 / P22/10_EwallObs 2022
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Lmphoblastic Leukaemia with Philadelphia chromosome or BCR::ABL1 positive
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients deceded and having previously refused data collection
- Not included in a prospective clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival by 12 months
Time frame: 12 months
10 secondary outcomes
overal survival by 36 months
Time frame: 36 months
proportion of complete remission
Time frame: 36 months
the molecular response defined by BCR//ABL1/ABL1 ratio in bone marrow and/or peripheral blood
Time frame: 36 months
the molecular response defined by IGTR quantification proportion in bone marrow and/or peripheral blood
Time frame: 36 months
Event free survival
Time frame: 36 months
Relapse free survival
Time frame: 36 months
the incidence ofBCR..ABL1 TK mutations
Time frame: 36 months
treatment tolerance
Time frame: 36 months
Death during induction
Time frame: 2 months
Death in complete remission
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by Versailles Hospital at 23 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandrine Roux (+33139239777, sroux@ght78sud.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival by 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.