Multicenter, open label, phase II clinical trial of inotuzumab ozogamicin as prophylaxis for relapse in patients with high-risk acute B-cell precursor acute lymphoblastic leukaemia after allogeneic stem cell haemotopoietic transplantation

Condition studied

Acute lymphoblastic leukaemia

Investigational medicinal product(s)

Eligibility

Primary endpoint

Evaluation of the efficacy of InO in terms of: • Relapse rate, defined as percentage of patients who experience a relapse after achieving complete remission. • CIR, defined as time interval between the date of complete remission and the date of relapse, considering any death not related to relapse as a competing event. • DFS, defines as time interval between the date of complete remission and relapse, death from any cause or last follow-up.

Endpoint detail

The safety profile of the treatment will be assessed based on: • Incidence of AEs. • Percentage of patients discontinuing therapy due to AEs. • Percentage of patients requiring dose modifications due to AEs. • Incidence of SAEs. • Changes in laboratory analysis from the hematology and blood chemistry panel. • Incidence of deaths and primary cause of death., Percentage of patients with MRD negativity prior to drug administration and at 3-, 6-, 9-, 12-, 18- and 22-months post allo-HSCT, evaluated by next generation flow cytometry (NGF) in BM, Analysis of the immune reconstitution in peripheral blood prior to drug administration and at 3-, 6-, 9-, 12-, 18- and 22-months post allo- HSCT, evaluated by immunophenotypic study (NGF) of specific markers of B-cells, T-cells and myeloid cells, among others, Analysis of the: Cumulative incidence of graft failure, defined as time interval from allo-HSCT to graft failure (failure to achieve sustained engraftment of donor cells). Cumulative incidence of acute GVHD (aGVHD), defined as time interval from allo-HSCT to aGVHD, staged and graded according to the MAGIC criteria previously published (29). Cumulative incidence of chronic GVHD (cGVHD) as time interval from allo-HSCT to cGVHD, based on the NIH criteria previously published, Comparison of the CIR and DFS obtained according to the description of primary objective with those obtained in patients who received allo- HSCT without exposure to InO, included and treated in the context of PETHEMA LAL-2025 protocol in the same period