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NCT Number: NCT07684131

EWALL-PH OBSERVARTORY 2022

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe hospitalier sud, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival by 12 months

    Time frame: 12 months

Secondary outcomes

  1. overal survival by 36 months

    Time frame: 36 months

  2. proportion of complete remission

    Time frame: 36 months

  3. the molecular response defined by BCR//ABL1/ABL1 ratio in bone marrow and/or peripheral blood

    Time frame: 36 months

  4. the molecular response defined by IGTR quantification proportion in bone marrow and/or peripheral blood

    Time frame: 36 months

  5. Event free survival

    Time frame: 36 months

  6. Relapse free survival

    Time frame: 36 months

  7. the incidence ofBCR..ABL1 TK mutations

    Time frame: 36 months

  8. treatment tolerance

    Time frame: 36 months

  9. Death during induction

    Time frame: 2 months

  10. Death in complete remission

    Time frame: 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Sandrine Roux

CONTACT

[email protected]

+33139239777

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Official study 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.

Acronym: Ewall Obs 2022

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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