Status:
COMPLETED
Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia
Lead Sponsor:
MedImmune LLC
Conditions:
Leukemia, Hairy Cell
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief 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 pa...
Detailed Description
Background: * Hairy cell leukemia (HCL) is an indolent B-cell leukemia comprising 2% of all leukemias, or approximately 900 of the 44,000 new cases of leukemia/year in the US * Over the last two deca...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01829711
Start Date
April 29 2013
End Date
April 29 2019
Last Update
April 8 2020
Active Locations (34)
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1
Research Site
Duarte, California, United States, 91010
2
Research Site
Los Angeles, California, United States, 90095
3
Research Site
Miami, Florida, United States, 33136
4
Research Site
Chicago, Illinois, United States, 60611