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Recruiting NCT07684131

EWALL-PH OBSERVARTORY 2022

— Observational Acute Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Primary outcome measures

  • Overall survival by 12 months [Time frame: 12 months]
Secondary outcome measures (10)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 23 centers
  • Groupe hospitalier sud — Amiens
  • CHU Angers — Angers
  • CH de la cote basque — Bayonne
  • CHU Bordeaux — Bordeaux
  • Hopital Militaire Percy — Clamart
  • CHU clermont ferrand — Clermont-Ferrand
  • Centre Hospitalier sud francilien — Corbeil-Essonnes
  • CHU de grenoble — Grenoble
  • … and 15 more centers

Identifiers

NCT: NCT07684131 · P22/10_EwallObs 2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗