EWALL-PH OBSERVARTORY 2022
NCT07684131 · Phase II · Amiens, France
- Condition
- Leukemia
- Disease stage
- Stage I-IV
- Phase
- Phase II
- Study type
- Targeted Therapy
- Age
- 18 Years to
- Gender
- All
- Sponsor
- Versailles Hospital
- Research institution
- Versailles Hospital
- Facility
- Groupe hospitalier sud
- Research center
- Groupe hospitalier sud
Summary
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.
Inclusion criteria
1. Male or female patients ≥ 18 years 2. Philadelphia chromosome or BCR::ABL1 positive acute lymphoblastic leukaemia 3. Treatment with the combination of BCR::ABL1 inhibitors and chemotherapy and/or corticotherapy and/or a monoclonal antibody
Exclusion criteria
1. Patients deceded and having previously refused data collection 2. Not included in a prospective clinical trial
Primary outcomes
Overall survival by 12 months
Secondary outcomes
overal survival by 36 months; proportion of complete remission; the molecular response defined by BCR//ABL1/ABL1 ratio in bone marrow and/or peripheral blood