A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA - A Ph2 Superiority Study with InO Monotherapy vs ALLR3 for Induction Treatment of Childhood HR A

Pfizer Inc.0 个研究点目标入组 100 人开始时间: 2023年1月6日最近更新: 2024年8月26日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Pfizer Inc.
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Male or female participants between 1 and less than 18 years of age.
•Type of Participant and Disease Characteristics:
•2. Morphologically confirmed diagnosis of first relapse HR BCP ALL;
•HR first relapse is defined as relapse occurring within 18 to 30 months of original diagnosis of ALL or within 6 months of completion of primary therapy, and lacking any identified very high risk genetic abnormalities (ie, KMT2A-rearrangements, TCF3-HLF, TCF3-PBX1, hypodiploidy, TP53 alteration)
•CD22-positive ALL as defined by local institution;
•Bone marrow involvement of = 5% leukemic blasts (= M2 status).
•Other Inclusion Criteria:
•3. Adequate serum chemistry parameters:
•An estimated glomerular filtration rate (eGFR) in participants 1 to less than 2 years of age, or estimated creatinine clearance (eCrCl) in those 2 to less than 18 years of age, =30 mL/min using the recommended formula
•Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =5 × institutional ULN at the time of randomization or pre-cytoreduction/general anesthesia;
•Total bilirubin =1.5 × institutional ULN unless the participant has documented Gilbert’s syndrome;
•4. Prior history of thrombosis during corticosteroid use and/or asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines.
•5. Cardiac shortening fraction = 30% by echocardiogram or ejection fraction > 50% by MUGA.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•Medical Conditions:
•1. Any history of:
•Prior or ongoing hepatic SOS or prior liver failure [defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of =1.5)];
•Prior allo-HSCT or CAR T-cell therapy;
•Isolated extramedullary leukemia
•Confirmed testicular relapse
•Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present;
•Presence of Grade 3 or Grade 4 peripheral neuropathy as defined in the Delphi consensus of acute toxic effects for childhood ALL (Schmiegelow et al, 2016);
•Intolerance to any of the ALLR3 agents (mitoxantrone, vincristine, dexamethasone, asparaginase, including history of asparaginase-associated acute pancreatitis, any grade as defined in the Delphi consensus (Schmiegelow et al, 2016);
•Grade 3 or Grade 4 allergic reaction to a monoclonal antibody;
•Participants not fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy, defined as resolution of all such non-hematologic toxicities to Grade =2 per the NCI CTCAE v 4.03 prior to randomization, with the exception of the laboratory abnormalities as defined by other inclusion/exclusion criteria;
•Down syndrome;
•Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
•2. Prior/Concomitant Therapy with:
•A calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin) or prior therapy with a CD22-targeted therapy (immunotoxin or CAR T-cell therapy);
•Cytotoxic therapy within 7 days prior to enrollment, with the exception of hydroxyurea and corticosteroids which are permitted prior to initiating study intervention. Participants may have received intrathecal chemotherapy at any time prior to study entry.
•NOTE: No waiting period is required for participants who relapse while receiving first-line maintenance chemotherapy.
•Any radiation therapy within 28 days prior to enrollment;
•The last dose of granulocyte stimulating factor (ie, Neupogen or equivalent) administered within 7 days prior to study enrollment and the last dose of pegfilgrastim (Neulasta®) given within 14 days prior to enrollment;
•Less than 3 half-lives elapsed after the last dose of a mAb (eg, rituximab=66 days, epratuzumab=69 days). Participants must not have received blinatumomab within 14 days before study enrollment;
•Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s).
•Prior/Concurrent Clinical Study Experience:
•3. Administration of an IP (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). A participant may be eligible if they are in the follow-up phase of an investigational study if they meet the criterion for time elapsed from previous administration of IP. Cases must be discussed with sponsor’s medical monitor to judge eligibility.
•Diagnostic Assessments:
•4. Serum or urine pregnancy test positive at screening.
•5. Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF interval >470 msec, complete LBBB, signs of an acut

研究者

发起方

Pfizer Inc.

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