Spots Global Cancer Trial Database for Study of Subcutaneous Campath-1H in Patients With B-Cell CLL and Residual Disease After Chemotherapy

Study Description

Brief Summary: To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate minimal residual disease (documented by flow cytometry) in patients who have achieved a complete remission (CR) or b) convert partial remission to complete remission. To evaluate the time-to-progression of patients according to pretreatment characteristics and response status at study entry. To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will eliminate minimal residual disease as determined by real-time quantitative PCR.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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