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Daratumumab with orwithout chemotherapyin relapsed andrefractory acutelymphoblasticleukemia. Aretrospectiveobservational CampusALL study Marco CerranoMassimiliano BonifacioMatteo Olivi2022 год

Daratumumab with or without chemotherapy in relapsed and refractory acute lymphoblastic leukemia. A retrospective observational Campus ALL study
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Аннотация: Daratumumab with or without chemotherapy in relapsed and refractory acute lymphoblastic leukemia. A retrospective observational Campus ALL studyThe anti-CD38 antibody daratumumab, currently approved for the treatment of patients with multiple myeloma, is also being explored for patients with acute lymphoblastic leukemia (ALL), whose blasts commonly express high levels of CD38. 1 Patients with relapsed or refractory (R/R) disease, as well as those with positive measurable residual disease (MRD) have consistently shown unfavorable outcomes and, especially for T-lineage ALL, therapeutic options beyond first-line treatment remain limited.Preclinical studies have demonstrated that daratumumab has significant activity in human xenograft models of ALL, both as a single agent and in combination with chemotherapy. 2-4However, the clinical experience is so far very limited.A few case reports have suggested that daratumumab has anti-leukemic activity in R/R and MRD-positive ALL cases, 5-10 but the small numbers of patients and the positive-outcome bias, due to the propensity to publish mainly positive results, prevent any robust conclusions on the clinical impact of this drug in ALL.We hereby report a retrospective, observational study performed in patients with R/R or MRD-positive ALL who received daratumumab in Italy in order to provide further information on the safety and efficacy of this drug in a real-life context.In this study we included adult and pediatric patients with R/R or MRD-positive T-or B-lineage ALL or lymphoblastic lymphoma, who received at least one dose of daratumumab between December 2018 and December 2020 at 17 Italian hematology centers.Data were retrospectively collected in an anonymous database.This study was performed in the context of the Campus ALL national framework and in agreement with the Declaration of Helsinki.Patients received daratumumab either off-label or in the context of a compassionate use program, kindly supported by Janssen-Cilag Spa.Daratumumab was administered at the approved schedule for multiple myeloma (i.e., 16 mg/kg weekly for 8 doses, then every 2 weeks for 8 doses, then monthly until disease progression), either alone or in combination with chemotherapy.The co-primary endpoints were overall response rate and overall survival of patients after daratumumab.Additional endpoints were safety and bridge to allogeneic hematopoietic cell transplant (HCT) after daratumumab.Complete response was defined as a bone marrow blast count <5% without evidence of extramedullary manifestations, partial response was defined as a bone marrow blast count ≥5% and <25% with a reduction of leukemic involvement of at least 50%.For lymphoblastic lymphoma, the Lugano criteria were applied.MRD was monitored either by flow cytometry and/or by real-time quantitative polymerase chain reaction in centralized laboratories.The overall response rate was defined as the proportion of patients who obtained a partial response, a complete response or, only for patients who were MRD positive, MRD negativity.Any systemic anti-neoplastic treatment started at diagnosis or with R/R disease counted as a line of therapy, except for allogeneic HCT.Survival was estimated using the Kaplan-Meier method and overall survival was calculated from the date of the first daratumumab infusion to the date of death or the last follow-up.The association of baseline variables with response was explored using the Fisher exact, c 2 or
Год издания: 2022
Авторы: Marco Cerrano, Massimiliano Bonifacio, Matteo Olivi, Antonio Curti, Michele Malagola, Michelina Dargenio, Anna Maria Scattolin, Cristina Papayannidis, Fabio Forghieri, Carmela Gurrieri, Ilaria Tanasi, Patrizia Zappasodi, Roberta La Starza, Nicola Fracchiolla, Patrizia Chiusolo, Luisa Giaccone, Maria Ilaria Del Principe, Fabio Giglio, Marzia Defina, Claudio Favre, Carmelo Rizzari, Barbara Castella, Giovanni Pizzolo, Felicetto Ferrara, Sabina Chiaretti, Robin Foà
Издательство: Ferrata Storti Foundation
Источник: Haematologica
Ключевые слова: Acute Lymphoblastic Leukemia research, Chronic Myeloid Leukemia Treatments, Chronic Lymphocytic Leukemia Research
Другие ссылки: Haematologica (PDF)
Haematologica (HTML)
PubMed Central (HTML)
Institutional Research Information System University of Turin (University of Turin) (PDF)
Institutional Research Information System University of Turin (University of Turin) (HTML)
PubMed (HTML)