Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.Greater than 5% blasts in the bone marrow.Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.relapse at any time after allogeneic HSCT.in untreated first relapse with first remission duration refractory to primary induction therapy or refractory to salvage therapy,.Subjects with Philadelphia negative B-precursor ALL, with any of the following: 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant.Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures? Grade 4: Life-threatening consequences urgent intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening hospitalization or prolongation of hospitalization indicated disabling limiting self care activities of daily living. Grade 2: Moderate minimal, local or noninvasive intervention indicated limiting age-appropriate instrumental activities of daily living. Duration of Complete Remission Īdverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild asymptomatic or mild symptoms clinical or diagnostic observations only intervention not indicated.The Kaplan-Meier estimate of EFS at 6 months is reported. Extramedullary relapse: extramedullary lesion that is new or increased by 50% from nadir as assessed by Cheson criteria.Progressive disease: An increase from baseline of at least 25% of bone marrow blasts or an absolute increase of at least 5,000 cells/μL in the number of circulating leukemia cells.Hematological relapse: proportion of blasts in bone marrow >5% or blasts in peripheral blood after documented CR or CRh* or CRi.Participants still alive and relapse-free were censored on their last disease assessment date.Ī relapse event was any one of the following: Participants who failed to achieve a CR/CRh*/CRi within 12 weeks of treatment initiation were considered as non-responders and assigned an EFS duration of 1 day.
#FIRST BITE SYNDROME CHEMOTHERAPY FREE#
The long-term follow-up part of the study was discontinued prematurely based on a recommendation from the data monitoring committee (DMC) that the study be stopped for benefit.Įvent free survival was defined as the time from randomization until a documented relapse after achieving CR/CRh*/CRi or death, whichever occurred first. A safety follow-up visit 30 days after the last dose of protocol-specified therapy and a long-term follow-up period were included. The study consisted of up to a 3-week screening and pre-phase period, a treatment period consisting of induction with 2 cycles of either blinatumomab or SOC chemotherapy, a consolidation phase of up to 3 additional cycles of protocol-specified therapy, and a maintenance phase for up to an additional 12 months with protocol-specified therapy. Randomization was stratified by age (< 35 years vs ≥ 35 years of age), prior salvage therapy (yes vs no), and prior allogeneic HSCT (yes vs no) as assessed at the time of consent. Why Should I Register and Submit Results?Īdults with relapsed/refractory B-cell precursor ALL were randomized in a 2:1 ratio to receive blinatumomab or 1 of 4 pre-specified, investigator-chosen, SOC chemotherapy regimens.
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