Status:
COMPLETED
Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
AL Amyloidosis
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to examine the tolerance, safety, pharmacokinetics, and possible clinical benefit of the good manufacturing practice (GMP)-grade amyloid fibril-reactive chimeric (Ch) IgG1...
Detailed Description
Presently, treatment of patients with amyloid light chain (AL) amyloidosis is limited to reducing production of the amyloid-forming light-chain protein by giving conventional or high-dose (with stem c...
Eligibility Criteria
Inclusion
- Patients must have a confirmed diagnosis of AL amyloidosis based on accepted clinical and laboratory criteria.
- Patients are greater than 21 years old.
- Female patients are not of child bearing potential or if they are of child bearing potential, they must not be pregnant or breast-feeding.
- Patients have a life expectancy greater than 3 months.
- Patients have an Eastern Cooperative Oncology Group (ECOG)-specified performance status of less than or equal to 3.
- Patients to be included are those with measurable, localized amyloid deposits (larynx, subcutaneous tissue, muscle, lung, lymph nodes) or clinically evident systemic disease (liver, kidney, heart, etc).
- Only patients with prior systemic therapy with relapsed/refractory disease are eligible, unless they have declined or are not eligible for high-dose melphalan and autologous hematopoietic stem cell transplant (HSCT) or any other standard therapy that has been known to be life-prolonging or life-saving.
- Patients have adequate organ function.
- Patients with cancer are eligible provided they meet specific criteria.
- Patients must provide signed, written, informed consent and be willing and able to comply with eligibility requirements, scheduled, visits, and follow-up studies.
Exclusion
- Non-AL amyloidosis.
- Renal failure (on dialysis).
- Females who are pregnant or breast-feeding.
- ECOG Performance Status greater than 3.
- Seriously limited cardiac, renal, or hepatic function.
- Uncontrolled infection or significant co-morbidity (e.g., uncontrolled diabetes, severe diarrhea).
Key Trial Info
Start Date :
October 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02245867
Start Date
October 30 2014
End Date
July 13 2017
Last Update
February 7 2025
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032