EsPhALL2017 / COGAALL1631
Research type
Research Study
Full title
International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones
IRAS ID
283413
Contact name
Michelle Cummins
Contact email
Sponsor organisation
University of Milano-Bicocca
Eudract number
2017-000705-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 11 months, 28 days
Research summary
Acute lymphoblastic leukaemia (ALL) is the most common childhood cancer with over 400 cases diagnosed each year in the UK. A small minority of young people with ALL test positive for the Philadelphia chromosome.
Patients will be registered into EsPhALL2017 once their Philadelphia status is known. Following induction chemotherapy (including the tyrosine kinase inhibitor imatinib which targets the Philadelphia chromosome), all patients will have a bone marrow biopsy to assess how much leukaemia is present by molecular testing (minimal residual disease/MRD). The MRD results will be used to allocate patients to one of two risk groups:
• Standard risk (low levels of MRD): Most patients fall into this group. These patients will be invited to take part in a research question investigating whether reduced intensity chemotherapy can control their ALL while reducing side-effects. Patients will be randomised to receive either standard (EsPhALL) backbone chemotherapy or reduced intensity (COG) backbone chemotherapy. Patients in both groups will receive imatinib throughout treatment.
• High risk (high levels of MRD): About 1-2 in 10 patients still have significant amounts of leukaemia in their bone marrow following induction. These patients require more intensive chemotherapy and, wherever possible, a stem cell transplant. These patients will be invited to take part in a research question investigating whether giving maintenance treatment with imatinib until a year after stem cell transplant can help prevent relapse, and whether the side-effects of maintenance treatment are tolerable.
Once they complete study treatment, patients will be followed up for a minimum of 3 years, during which time data will be collected about their disease status. Standard risk patients will also have a small number of additional tests to investigate how treatment affects heart function, bone development and growth.
EsPhALL2017 is an international collaborative trial. 700 patients will be recruited, including 60 from the UK.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0001
Date of REC Opinion
21 Jan 2022
REC opinion
Favourable Opinion