Status:
WITHDRAWN
Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Hodgkin's Disease
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary Objective: To determine the safety and efficacy of Campath-1H (Alemtuzumab) in patients with relapsed and resistant classical Hodgkin's lymphoma. Secondary Objectives: 1. To determine the d...
Detailed Description
Alemtuzumab is the type of drug known as a "monoclonal antibody". The antibody binds to a specific protein (antigen) called CD52. CD52 is found on the surface of normal lymphocytes and monocytes. When...
Eligibility Criteria
Inclusion
- Relapsed or refractory Hodgkin's disease with a minimum of 2 prior treatment regimens, including autologous bone marrow transplantation.
- Must have histologically proven diagnosis of nodular sclerosis or mixed cellularity Hodgkin's disease.
- Hodgkin's lymphoma should be limited to lymph nodes, spleen, and bone marrow.
- Must have bi-dimensionally measurable disease defined as a lymph node at least 2 cm by computed tomography (CT) scan.
- Platelet count equal to or greater than 50,000/uL; absolute neutrophil count equal to or greater than 1,000/uL.
- Must sign a consent form.
- Males or females equal to or greater than 18 years of age.
- Patients may be taking voriconazole, itraconazole, or diflucan.
Exclusion
- No serious inter-current infections requiring therapy.
- No Hodgkin-specific therapy within the last 3 weeks.
- Pregnant women and women of childbearing potential and men of reproductive potential who are not practicing adequate contraception.
- Lymphocyte depletion or lymphocyte predominance histology.
- History of HIV infection.
- Central nervous system (CNS) involvement with lymphoma including epidural disease and cord compression.
- Prior allogeneic stem cell transplantation.
- Patients receiving steroids within 3 weeks of registration.
- Patients with a history of prior severe opportunistic infections that are controlled by T-cell immunity, such as pneumocystis pneumonia (PCP), herpes virus infections, mycobacterial disease, invasive mold infections or endemic fungi.
- Patients with an ejection fraction of less than 40%.
Key Trial Info
Start Date :
June 22 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00129753
Start Date
June 22 2005
End Date
September 5 2006
Last Update
November 8 2018
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