A Clinical Research Consortium (CRC) Phase II Study of Subcutaneous Campath-1H in Patients With B-Cell Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy
Approximately 95% of cases involve the clonal proliferation of B cells. Paraproteins, often
of the IgM class, can be detected in the serum and/or urine of most patients with CLL.
Unique cell surface markers are increasingly being used to diagnose the disease, and in
approximately 40% of patients, cytogenetic abnormalities (for example, trisomy 12) can be
found. Patients commonly present with lymphocytosis, lymphadenopathy, splenomegaly and
symptoms of fatigue, weight loss, and malaise. In more advanced cases anemia and
thrombocytopenia can also occur. The clinical course of CLL is unpredictable, with survival
from initial diagnosis varying from 1 to 20 years (2). In addition, there is a subset of
patients with indolent CLL whose absolute lymphocyte count is less than 30 x 109/L and who
rarely die from the disease.
CLL is commonly staged according to the 5-point system proposed by Rai (Appendix B) and
co-workers. While Rai staging is a relatively good predictor of overall survival, it cannot
predict the prognosis in individual patients.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate residual disease (documented by flow cytometry) or b) convert partial remission to complete remission
Response evaluation at end of each course (4 weeks of therapy) (within 0-8 weeks). Patients followed until progressive disease is documented or death
Thomas Kipps, MD, PhD
Director, Chronic Lymphocytic Leukemia Research Consortium
United States: Food and Drug Administration
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|University of California San Diego||La Jolla, California 92093|