B-Cell Chronic Lymphocytic Leukemia MedDRA version: 8.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia
Conditions
Interventions
Trade Name: CAMPATH/MabCampath
Product Name: MabCampath
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: alemtuzumab
Sponsors
Genzyme Europe BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) A diagnosis of B-CLL; according to the NCIWG Criteria (Appendix D) (2) At least 18 years old (3) World Health Organization (WHO) performance status of 0, 1, or 2 (4) Life expectancy =12 weeks (5) Previous therapy with at least one but no more than five regimens (single agent or combination regimen). One regimen is defined as consecutive, contiguous cycles of the same drug(s) with no treatment interruptions lasting >3 months. (6) Patient requires treatment for chronic lymphocytic leukemia (CLL) per the following criteria * Rai stage III or IV (Appendix D). * Rai stage 0-II with at least one of the following: - Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia - Massive (i.e., >6 cm below the left costal margin) or progressive splenomegaly - Progressive lymphocytosis with an increase of >50% over a 2 month period or an anticipated doubling time of 100 ×109/L - B symptoms (7) More than 3 weeks since prior chemotherapy. Patient must have recovered from the acute side effects incurred as a result of previous therapy. (8) More than 3 weeks since using investigational agents. Patient must have recovered from the acute side effects incurred as a result of previous therapy. (9) Serum creatinine and conjugated (direct) bilirubin =2 x the institutional upper limit of normal (ULN) unless secondary to direct infiltration of the liver with CLL. (10) Female patients with childbearing potential must have a negative pregnancy test (serum or urine) within 2 weeks of first dose of study drug(s). All patients must agree to use an effective contraceptive method while on study treatment, if appropriate, and for a minimum of 6 months following study therapy. (11) Signed, written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) Positive Coombs test and evidence of active hemolysis (2) Platelet count <50 ×109/L without splenomegaly (3) History of anaphylaxis following exposure to rat or mouse derived CDR grafted humanized monoclonal antibodies (4) Previously treated with CAMPATH (5) Previous bone marrow transplant (6) Known central nervous system (CNS) involvement with B-CLL (7) Active infection, including human immunodeficiency virus (HIV) positive (8) Active secondary malignancy (9) Recent documented history (within 2 years) of active tuberculosis (TB), current active TB infection, currently receiving anti-tuberculous medication (e.g., isoniazid, rifampin, streptomycin, pyrazinamide, or others) (10) Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive hepatitis B serologies. Patients with a positive hepatitis B surface antibody (HBsAb) test with a documented history of prior hepatitis B immunization are eligible as long as other criteria are met (ie, negative tests for: hepatitis B surface antigen [HBsAg], hepatitis B core antibody [HBcAb] and hepatitis C virus antibody [HCVAb]). (11) Other severe, concurrent diseases (e.g., cardiac or pulmonary disease), mental disorders, or major organ malfunction (liver, kidney) that could interfere with the patient’s ability to participate in the study (12) Pregnant or nursing women (13) Cytomegalovirus (CMV) positive by polymerase chain reaction (PCR) (above the level of detection). A patient that is PCR positive will require treatment to reduce the viral load to a non-detectable level, but such a patient may be reconsidered for study entry once the infection has been treated (see Section 6.1.1). (14) Medical condition requiring chronic use of oral corticosteroids at a dose higher than physiologic replacement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine best disease response to treatment with CAMPATH administered subcutaneously (SC) for up to 18 weeks in patients with B-Cell Chronic Lymphocytic Leukemia (B CLL) who have been previously treated.; Secondary Objective: Secondary objectives are to determine the •Progression free survival (PFS) •Duration of response •Overall survival •Minimal residual disease (MRD) status by flow cytometry analysis of bone marrow and peripheral blood •And to evaluate the safety of CAMPATH administered SC ; Primary end point(s): The primary efficacy endpoint is the best overall response rate for up to 18 weeks of CAMPATH administered SC using the National Cancer Institute Working Group (NCIWG) criteria for determining response. Overall response rate = Number of CR (complete repons) + PR (partial respons) patients / numbers of patients in full analysis set | — |
Countries
Belgium, Czech Republic, United Kingdom
Outcome results
None listed