A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia
Condition: Hairy Cell Leukemia
MeSH terms: Leukemia; Leukemia, Hairy Cell
Intervention: Moxetumomab Pasudotox (CAT 8015); Moxetumomab Pasudotox (CAT 8015); Moxetumomab Pasudotox (CAT 8015); Moxetumomab Pasudotox (CAT 8015); CAT 8015 (Moxetumomab Pasudotox); Moxetumomab Pasudotox (CAT 8015)
Intervention description: Participants received intravenous infusion of 5 microgram per kilogram (mcg/kg) moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.; Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.; Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.; Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.; Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.; Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
Intervention MeSH terms: Immunotoxin HA22
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: CAT-8015; Moxetumomab pasudotox

Summary:

      A dose-escalation study to identify the dose-limiting toxicity (DLT) and maximum tolerated
      dose (MTD), defined as the highest dose that can safely be given to a participant and
      establish the safest dose based on the highest tolerated dose for clinical testing.
    

Eligibility criteria:

        Inclusion Criteria: Confirmed diagnosis of HCL, Measurable disease, Participant's must have
        had at least 2 prior systemic therapies. There must have been at least 2 prior courses of
        purine analog, or 1 if the response to this course lasted less than (<) 2 years, or if the
        participant had unacceptable toxicity to purine analog, Eastern Cooperative Oncology Group
        (ECOG) performance status of 0-2, Participant's with other cancers who meet eligibility
        criteria and have less than 5 years of disease free survival will be considered on a
        case-by-case basis, Life expectancy of greater than 6 months, as assessed by principal
        investigator, Must be able to understand and sign informed consent, Must be at least 18
        years old, Female and male participants must agree to use an approved method of
        contraception during the study.

        Exclusion Criteria: - History of allogeneic bone marrow transplant, Documented and ongoing
        central nervous system involvement with their malignant disease (history of central nervous
        system (CNS) involvement is not an exclusion criteria), Pregnant or breast-feeding females,
        HIV positive serology (due to increased risk of severe infection and unknown interaction of
        CAT-8015 with antiretroviral drugs, Hepatitis B surface antigen positive. - Hepatic
        function: Serum transaminases (either alanine transaminase (ALT) or aspartate transaminase
        (AST)) or bilirubin: greater than or equal to (>=) Grade 2, unless bilirubin is due to
        Gilbert's disease. -Renal function: Serum creatinine clearance less than or equal to (<=)
        60 millilitre per minute (mL/min) as estimated by Cockroft-Gault formula. -Hematologic
        function: The absolute neutrophil count (ANC) < 1000/ cubic millimetres (cmm), or platelet
        count <50,000/cmm, if these cytopenias are not judged by the investigator to be due to
        underlying disease (i.e. potentially reversible with anti-neoplastic therapy). -Pulmonary
        function: Participant's with < 50% of predicted forced expiratory volume (FEV1) or <50% of
        predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin
        concentration and alveolar volume. Uncontrolled pulmonary infection, presence of pulmonary
        edema, Oxygen saturation at rest < 88% measured by pulse oximetry or partial pressure of
        oxygen (PaO2) < 55 millimetre(s) of mercury (mm Hg), Serum albumin < 2 g/dL,
        Radioimmunotherapy within 2 years prior to enrollment in study.