Ph Positive ALLEVOLALPh1NCT07433400
Long-term Progression of Patients Treated and Monitored for Relapsed or Refractory Ph+ ALL
An observational study of Ph Positive ALL, run by Group for Research in Adult Acute Lymphoblastic Leukemia at 1 site in France.
Trial summary
The objective of this retrospective study is to examine the outcome of patients who relapse with Ph+ ALL and to potentially identify response profiles in order toadvance the treatment regimens that can be offered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ph Positive ALL
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2025to 31 Dec 2035
- How long will I take part?
- 15 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: Patient treated by TKI
Who may be able to join
- Age >= 18
- Relapse or refractory Ph1 ALL
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
GRAALL
Pierre-Bénite, 69310
Aline SCHMIDT, MD/PhD, 02 41 35 44 82 ext. 33, alschmidt@chu-angers.fr
About this study
Official title: Retrospective Study of the Long-term Progression of Patients Treated and Monitored for Relapsed or Refractory Ph+ ALL
The objective of this retrospective study is to examine the outcome of patients who relapse with Ph+ ALL and to potentially identify response profiles in order toadvance the treatment regimens that can be offered.
- Conditions
- Ph Positive ALL
- Keywords
- 1ST RELAPSE OR MORE, TKI
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term survival
Measured: 5 years
Secondary outcomes (8)
10 year-survival
Measured: 10 years
Molecular response (BCR::ABL1 ratio)
Molecular response is assessed using BCR::ABL1 ratio, on bone marrow if available (if not, on blood)
Measured: At the end of each line of treatment, at each relapse, at 5 years after the last relapse, at 10 years after the last relapse
Hematologic response
Hematologic response is defined by less than 5% of blasts on bone marrow aspiration
Measured: At the end of each line of treatment, at each relapse, at 5 years after the last relapse, at 10 years after the last relapse
Death date
Measured: Up to 10 years
Cause of death
Cause of death can be : 1)disease, 2)complications related to treatment except bone marrow transplant, 3)Hematopoietic Stem Cells Transplantation related, 4)other
Measured: Up to 10 years
Treatment characteristics (treatment name)
Name of chemotherapy or immunotherapy used
Measured: At day 1 of each new treatment of relapse
Treatment characteristics (treatment dates)
Start date and end date of treatment
Measured: At day 1 and at the end of each line of treatment of relapse
Treatment characteristics (dose)
Dose of each treatment
Measured: At day 1 of each new treatment of relapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start29 Aug 2025
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ph Positive ALLStudies 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
- 500 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Group for Research in Adult Acute Lymphoblastic Leukemia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433400
- Sponsor's protocol ID
- EVOLALPh1
- Acronym
- EVOLALPh1
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of the Long-term Progression of Patients Treated and Monitored for Relapsed or Refractory Ph+ ALL
- ClinicalTrials.gov ID
- NCT07433400
- Acronym / sponsor ID
- EVOLALPh1 / EVOLALPh1
- Conditions
- Ph Positive ALL
- Keywords
- 1ST RELAPSE OR MORE, TKI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Group for Research in Adult Acute Lymphoblastic LeukemiaUniversity, hospital or other
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 25 Feb 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.
The objective of this retrospective study is to examine the outcome of patients who relapse with Ph+ ALL and to potentially identify response profiles in order toadvance the treatment regimens that can be offered.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient treated by TKI
Key inclusion criteria (2 listed)
- Age >= 18
- Relapse or refractory Ph1 ALL
Key exclusion criteria (1 listed)
- none
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
Long term survival
Time frame: 5 years
8 secondary outcomes
10 year-survival
Time frame: 10 years
Molecular response (BCR::ABL1 ratio)
Time frame: At the end of each line of treatment, at each relapse, at 5 years after the last relapse, at 10 years after the last relapse
Hematologic response
Time frame: At the end of each line of treatment, at each relapse, at 5 years after the last relapse, at 10 years after the last relapse
Death date
Time frame: Up to 10 years
Cause of death
Time frame: Up to 10 years
Treatment characteristics (treatment name)
Time frame: At day 1 of each new treatment of relapse
Treatment characteristics (treatment dates)
Time frame: At day 1 and at the end of each line of treatment of relapse
Treatment characteristics (dose)
Time frame: At day 1 of each new treatment of relapse
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 25 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ph Positive ALL, run by Group for Research in Adult Acute Lymphoblastic Leukemia at 1 site 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 2 inclusion and 1 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 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Aline SCHMIDT, MD/PhD (241354482 ext. 33, alschmidt@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term survival (time frame: 5 years). 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 25 Feb 2026.