Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia
Condition: Leukemia, Hairy Cell
MeSH terms: Leukemia; Leukemia, Hairy Cell
Intervention: Moxetumomab pasudotox; IV Bag Protectant for Moxetumomab pasudotox
Intervention MeSH terms: Immunotoxin HA22; Protective Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Moxetumomab Pasudotox; CAT-8015; Anti-cd22 recombinant immunotoxin; Biologic Therapy; Monoclonal Antibody; Pseudomonas Exotoxin; Targeted Therapy

Summary:

      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.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Patients must have histologically confirmed hairy cell leukemia or hairy cell leukemia
             variant .with a need for therapy

          -  Patients must be Pseudomonas-immunotoxin naive

          -  Patients must have had at least 2 prior purine analogs, or at least 1 course of purine
             analog and 1 of either rituximab or BRAF inhibitor.

          -  Men or women age greater than or equal to 18 years.

          -  ECOG performance status less than or equal to 2.

          -  Patients must have adequate organ function

        EXCLUSION CRITERIA

          -  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