A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia

PHASE1CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

May 10, 2007

Primary Completion Date

May 6, 2015

Study Completion Date

May 6, 2015

Conditions
Hairy Cell Leukemia
Interventions
DRUG

Moxetumomab Pasudotox (CAT 8015)

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.

DRUG

Moxetumomab Pasudotox (CAT 8015)

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.

DRUG

Moxetumomab Pasudotox (CAT 8015)

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.

DRUG

Moxetumomab Pasudotox (CAT 8015)

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.

DRUG

CAT 8015 (Moxetumomab Pasudotox)

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.

DRUG

Moxetumomab Pasudotox (CAT 8015)

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.

Trial Locations (4)

20892

Research Site, Bethesda

60611

Research Site, Chicago

94305

Research Site, Stanford

93-510

Research Site, Lodz

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Cambridge Antibody Technology

OTHER

lead

MedImmune LLC

INDUSTRY