A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia
Condition: Hairy Cell Leukemia
MeSH terms: Leukemia; Leukemia, Hairy Cell
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      A Phase 1, multicenter, dose escalation study of moxetumomab pasudotox (CAT-8015) in
      participants with relapsed or refractory hairy cell leukemia (HCL) to estimate the MTD,
      defined as the highest dose that can be safely administered to a patient, and to establish a
      safe dose, based on the MTD, for subsequent clinical testing (Phase 2 recommended dose).
    

Intervention name(s): 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 type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CAT-8015; Moxetumomab pasudotox