NCT07433400

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
118mo left

Started Aug 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Aug 2025Dec 2035

Study Start

First participant enrolled

August 29, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

10.3 years

First QC Date

January 20, 2026

Last Update Submit

February 24, 2026

Conditions

Ph Positive ALL

Keywords

1ST RELAPSE OR MORETKI

Outcome Measures

Primary Outcomes (1)

  • Long term survival

    5 years

Secondary Outcomes (8)

  • 10 year-survival

    10 years

  • Molecular response (BCR::ABL1 ratio)

    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

    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

    Up to 10 years

  • Cause of death

    Up to 10 years

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient treated by TKI

You may qualify if:

  • Age \>= 18
  • Relapse or refractory Ph1 ALL

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GRAALL

Pierre-Bénite, 69310, France

RECRUITING

Central Study Contacts

Aline SCHMIDT, MD/PhD

CONTACT

241354482alschmidt@chu-angers.fr

Véronique LHERITIER, Central coordination

CONTACT

0478862239veronique.lheritier@chu-lyon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 25, 2026

Study Start

August 29, 2025

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2035

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

FR(1)