Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia

• Status: Completed
• Trial end date: 2019-04-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC
• Treatments: Immunotoxin HA22; Immunotoxins; Protective Agents

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