Long-term Progression of Patients Treated and Monitored for Relapsed or Refractory Ph+ ALL (EVOLALPh1)

February 24, 2026 updated by: Group for Research in Adult Acute Lymphoblastic Leukemia

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Pierre-Bénite, France, 69310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient treated by TKI

Description

Inclusion Criteria:

  • Age >= 18
  • Relapse or refractory Ph1 ALL

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Long term survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 year-survival
Time Frame: 10 years
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
Molecular response is assessed using BCR::ABL1 ratio, on bone marrow if available (if not, on blood)
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
Hematologic response is defined by less than 5% of blasts on bone marrow aspiration
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
Up to 10 years
Cause of death
Time Frame: Up to 10 years
Cause of death can be : 1)disease, 2)complications related to treatment except bone marrow transplant, 3)Hematopoietic Stem Cells Transplantation related, 4)other
Up to 10 years
Treatment characteristics (treatment name)
Time Frame: At day 1 of each new treatment of relapse
Name of chemotherapy or immunotherapy used
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
Start date and end date of treatment
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
Dose of each treatment
At day 1 of each new treatment of relapse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Group for Research in Adult Acute Lymphoblastic Leukemia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2025

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EVOLALPh1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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