Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia

Completed · Phase 3

Conditions studied: Leukemia, Hairy Cell

In brief

Background: \- Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a phase I trial it had activity in relapsed/refractory hairy cell leukemia with safety profile supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053). This is a phase III multicenter trial designed to confirm these results.

Key facts

Study ID

NCT01829711

Run by

MedImmune LLC

People needed

80

Starts

2013-04-29

Expected to finish

2019-04-29

Last updated by the study team

2020-04-08

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to entering the study.
• Patients who are receiving any other investigational agents.
• Patients with known brain metastases should be excluded from this clinical trial
• Patients with clinically significant ophthalmologic findings during screening
• Pregnant or breastfeeding females.
• Positive for Hepatitis B core antibody or surface antigen unless the patient is on Lamivudine or Entecavir and Hepatitis B Viral DNA load is less than 2000 IU/mL.
• Active second malignancy requiring treatment other than minor resection of indolent cancers like basal cell and squamous skin cancers
• HIV-positive patients unless taking appropriate anti-HIV medications with a CD4 count of greater than 200.
• History of allogeneic bone marrow transplant.
• Patients with history of both thromboembolism and known congenital hypercoagulable conditions.
• Uncontrolled pulmonary infection, pulmonary edema.
• Adequate oxygen saturation
• Radioimmunotherapy within 2 years prior to enrollment in study.
• Adequate hematologic function
• Adequate lung function
• Patients with history of thrombotic microangiopathy or thrombotic microangiopathy / hemolytic uremic syndrome
• Patients with QTc interval (Friderica) elevation > 500 msec based on at least 2 separate 12-lead ECGs
• Patient on high dose estrogen
• Patients with clinical evidence of disseminated intravascular coagulation

Where it is running

• Research Site — Duarte, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Miami, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — New York, New York, United States
• Research Site — Houston, Texas, United States
• Research Site — Antwerp, Belgium
• Research Site — Ghent, Belgium
• Research Site — Edmonton, Alberta, Canada
• Research Site — Brno, Czechia
• Research Site — Caen, France
• Research Site — Le Chesnay, France
• Research Site — Pessac, France
• Research Site — Pierre-Bénite, France
• Research Site — Rouen, France
• Research Site — Strasbourg, France
• Research Site — Berlin, Germany
• Research Site — Giessen, Germany
• Research Site — Heidelberg, Germany
• Research Site — Dublin, Ireland
• Research Site — Haifa, Israel
• Research Site — Bologna, Italy

Full record on ClinicalTrials.gov

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