ASH 2022 | Results of Phase III UKALL 2011 study: impact of high-dose methotrexate on CNS relapse in ALL

High-dose methotrexate is the most common chemotherapeutic agent used against acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). Treatment with chemotherapeutic agents like methotrexate is associated with short- and long-term adverse effects. Ajay Vora, MD, Great Ormond Street Hospital, London, UK, presents results at ASH from UKALL 2011 (EudraCT 2010-020923-22), a randomized Phase III study that aimed to improve safety in children and young adults with ALL and LBL by investigating central nervous system relapse (CNSR) and maintenance morbidity. The CNSR associated with HDM was compared to standard interim maintenance (SIM) in a methotrexate randomization treatment arm (R2IM). Another pulses randomization treatment arm (R2pulses) assessed maintenance morbidity in patients receiving SIM with vincristine/dexamethasone pulses to those not receiving pulses – using bone marrow relapse rate in ALL patients as the primary endpoint. For both R2IM and R2pulses, event-free survival (EFS) was also a primary endpoint. Ultimately, no difference in CNSR was observed between the HDM and SIM treatments for any of the R2IM endpoints. However, it was found that patients treated with standard dexamethasone and HDM showed improved outcomes when compared to patients with standard dexamethasone without HDM – with respect to bone marrow relapse rate and overall survival. For R2pulses, patients treated with SIM but without vincristine/dexamethasone pulses were found to have lower EFS. However, pulses did not show any appreciable benefit compared to no pulses in HDM-treated patients. This press briefing took place at the 64th ASH Annual Meeting and Exposition congress in New Orleans, LA.

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