Abstract
Relapse was the major cause of treatment failure in patients with acute lymphoblastic leukemia (ALL) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). We aimed to identify the efficacy and safety of preemptive interferon-α (IFN-α) treatment in ALL patients who had minimal residual disease (MRD) after allo-HSCT. Multiparameter flow cytometry and polymerase chain reaction assays were applied for MRD monitoring. Recombinant human IFN-α-2b injections were administered subcutaneously twice weekly in every 4 weeks cycle. Twenty-four (35.3%), 5 (7.4%), 6 (8.8%), and 13 (19.1%) patients achieved MRD negativity at 1, 2, 3, and > 3 months, respectively, after treatment. Seven patients showed grade ≥ 3 toxicities after IFN-α treatment. The 4-year cumulative incidence of total acute graft-versus-host disease (aGVHD), severe aGVHD, total chronic GVHD (cGVHD), and severe cGVHD after treatment was 14.7%, 2.9%, 40.0%, and 7.5%, respectively. The 4-year cumulative incidences of relapse and non-relapse mortality after treatment was 31.9% and 6.0%, respectively. The 4-year probabilities of disease-free survival and overall survival after IFN-α treatment were 62.1% and 71.1%, respectively. Thus, preemptive IFN-α treatment could protect against relapse and improve long-term survival for ALL patients who had MRD after allo-HSCT. The study was registered at https://clinicaltrials.gov as #NCT02185261 (09/07/2014).
Highlights
Relapse was the major cause of treatment failure in patients with acute lymphoblastic leukemia (ALL) after allogeneic hematopoietic stem cell transplantation
Multiparameter flow cytometry (MFC) identified cells with leukemia-associated immunophenotypes (LAIPs) and polymerase chain reaction (PCR) assays detected leukemia-associated genetic abnormalities, both could be applied for monitoring minimal residual disease (MRD) in leukemia patients
These results identify the undefined role of this intervention strategy in ALL patients following allo-HSCT
Summary
Relapse was the major cause of treatment failure in patients with acute lymphoblastic leukemia (ALL) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). We aimed to identify the efficacy and safety of preemptive interferon-α (IFN-α) treatment in ALL patients who had minimal residual disease (MRD) after allo-HSCT. Chemotherapy plus donor leukocyte infusion (Chemo-DLI) was the most effective preemptive intervention for MRD6,7, it may lead to some severe complications (e.g., graft-versus-host disease [GVHD] and pancytopenia)[8]. It was out of choices for some patients because of related donor refusal or unavailability of the second donation from an unrelated donor. We further confirmed that preemptive IFN-α treatment can clear the MRD effectively in patients with acute leukemia and high-risk myelodysplastic syndrome after allo-HSCT4,20–22. The long-term efficacy of preemptive IFN-α treatment remains unknown in ALL patients following allo-HSCT
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