Leukemia
Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients with Chronic Lymphocytic Leukemia
Eligibility Criteria (Per Protocol dated 01/09):
- Diagnosis of B-CLL, as defined by NCI criteria.
- Subject must require chemotherapy. The last administration of chemotherapy must have been completed for at least 6 weeks prior to study treatment.
- Subject must have either: 1) Demonstrated progression after at least one cycle of either an alkylating agent-based or purine nucleoside based regimen, 2) Failed to achieve a meaningful response, or 3) Relapsed after prior therapy. Subjects who have relapsed with a pentostatin-based regimen may be eligible if the response was greater than 12 months.
- Subject must have received prior Rituximab therapy, but at least 8 weeks should have elapsed between the last Rituximab dose and registration.
- Subject must not have had previous Campath-1H therapy prior to entering the study. Subjects may have had previous PCR therapy or components thereof; however, they must have completed pentostatin and cyclophosphamide for at least 1 year from the date of registration.
- Subjects with grade III or IV heart failure according to the New York Heart Association functional classification are not eligible.
- Subjects whose marrow function is attributable to dysplasia related to prior therapy are not eligible.
- Subjects must have ECOG Performance status of 0-2.
- Subjects must be tested for hepatitis B virus infection. Those who are carriers of the virus or who test positive for the virus will be allowed to enter the study, but will be closely monitored for clinical and laboratory signs of active HBV infection and hepatitis.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.