Lymphoplasmacytic Lymphoma Clinical Trial
Official title:
Phase II Study of Campath-1H in Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Verified date | December 2012 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma.
Status | Completed |
Enrollment | 27 |
Est. completion date | June 2008 |
Est. primary completion date | October 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's macroglobulinemia - Adequate organ function: ANC > 500/ul; PLT > 25,000/ul; serum creatinine < 2.5; serum total bilirubin and SGOT < 2.5 times the upper normal limit. - Age greater than 18 years - Life expectancy of 6 months or greater - ECOG performance status of 0-2 Exclusion Criteria: - Chemotherapy, steroid therapy, or radiation therapy within 21 days of study entry. - Prior Campath-1H or monoclonal antibody therapy within 3 months of study entry. - Pregnant women - Serious co-morbid disease, uncontrolled bacterial, fungal, or viral infection. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Beth Isreal Deaconness Medical Center | Boston | Massachusetts |
United States | Dana-farber Cancer Insitiute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Arizona Oncology Associates, Bayer, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital, Northwestern University, University of California, Los Angeles |
United States,
Treon SP, Soumerai JD, Hunter ZR, Patterson CJ, Ioakimidis L, Kahl B, Boxer M. Long-term follow-up of symptomatic patients with lymphoplasmacytic lymphoma/Waldenström macroglobulinemia treated with the anti-CD52 monoclonal antibody alemtuzumab. Blood. 201 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia. | 2 years | No | |
Secondary | To determine the safety of Campath-1H. | 2 years | Yes |
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