CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
Condition: Acute Lymphoblastic Leukemia; Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: CAT-8015 (Moxetumomab Pasudotox); CAT-8015 (Moxetumomab Pasudotox); CAT-8015 (Moxetumomab Pasudotox); CAT-8015 (Moxetumomab Pasudotox); CAT-8015 (Moxetumomab Pasudotox); CAT-8015 (Moxetumomab Pasudotox); CAT-8015 (Moxetumomab Pasudotox); CAT-8015 (Moxetumomab Pasudotox); CAT-8015 (Moxetumomab Pasudotox); CAT-8015 (Moxetumomab Pasudotox)
Intervention description: Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.; Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.; Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.; Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.; Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.; Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.; Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.; Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.; Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.; Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Intervention MeSH terms: Immunotoxin HA22
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 6 Months
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Moxetumomab pasudotox

Summary:

      A dose-escalation study to estimate maximum cummulative dose (MTCD) of CAT-8015 that can be
      safely administered to a participant.
    

Eligibility criteria:

        Inclusion Criteria:

        - Histologically confirmed diagnosis of acute lymphoblastic leukemia (ALL) or non-Hodgkin's
        lymphoma (NHL) including lymphoblastic lymphoma, Burkitt's lymphoma, and large cell
        lymphoma; - Measurable or evaluable disease. - Evidence of CD22-positive malignancy by one
        of the following criteria: - greater than or equal to (>=) 30 % of malignant cells from a
        disease site cluster of differentiation 22+ (CD22+) by fluorescence-activated cell sorter
        (FACS) analysis or; ≥ 15 % of malignant cells from a disease site CD22+ by
        immunohistochemistry (IHC). Stage of disease: - Participants must have relapsed or
        refractory disease and have received at least one standard chemotherapy and one salvage
        regimen or allogeneic stem cell transplant; - Relapse after prior autologous or allogeneic
        HSCT is allowed. In the event of relapse after prior allogeneic HSCT, the participant must
        be at least 100 days post-transplant and have no evidence of ongoing active graft-vs-host
        disease; - Recovered from the acute toxic effects of all prior therapy before entry.
        Performance status: - Participants greater than or equal to (>=) 12 years of age: Eastern
        Cooperative Oncology Group (ECOG) score of 0, 1, 2, or 3; - Participants < 12 years of age:
        Lansky scale >= 50%; - Participants who are unable to walk because of paralysis, but who
        are up in a wheel chair will be considered ambulatory for the purpose of calculating the
        performance score. Participants with the following central nervous system (CNS) status, are
        eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as
        cranial nerve palsy. - Female and male participants with childbearing potential and their
        sexual partners must agree to use an approved method of contraception during the study.

        Exclusion Criteria:

        - Participants meeting any of the following criteria are not eligible for participation in
        the study: - Isolated testicular or CNS ALL; Hepatic function: - Inadequate liver function
        defined as total bilirubin > 2 × upper limit of normal (ULN) (except in the case of
        participants with documented Gilbert's disease > 5 × ULN) or transaminases (ALT and
        aspartate aminotransferase [AST]) > 5 × ULN based on age- and laboratory-specific normal
        ranges; Renal function: - With greater than age-adjusted normal serum creatinine (see Table
        below) and a creatinine clearance > 60 millilitre per minute mL/min/1.73 m2. - Age(Years)-
        Maximum Serum Creatinine (mg/dl)[≤5,0.8] [5 < age less than or equal to 10,1.0] [10 < age
        less than or equal to 15,1.2 [> 15, 1.5] Hematologic function: - For non-leukemic subjects
        only, absolute neutrophil count (ANC) < 1000/cmm, or platelet count < 50,000/cmm, if these
        cytopenias are not judged by the investigator to be due to underlying disease (ie
        potentially reversible with anti-neoplastic therapy); - Participants with CNS 3 disease; -
        Hyperleukocytosis (≥ 50,000 blasts/µL) or rapidly progressive disease (PD) that in the
        estimation of the investigator and sponsor would compromise ability to complete study
        therapy; - Prior treatment with CAT-3888 (BL22) or any pseudomonas-exotoxin-containing
        compound; - HIV positive serology (due to increased risk of severe infection and unknown
        interaction of CAT-8015 with antiretroviral drugs); - Active hepatitis B or C infection.