A single-arm, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with B-cell Chronic Lymphocytic Leukemia who have failed fludarabine and alemtuzumab

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

The trial population will be comprised of patients with a diagnosis of B-CLL who have failed both fludarabine and alemtuzumab and who have received an alkylating therapy such as cyclophosphamide or chlorambucil and who have active disease. Active B-CLL is defined and confirmed according to the NCIWG guidelines 1 and with an indication for treatment. Failing at least one fludarabine-containing treatment regimen is defined as 1. Refractory to one fludarabine -containing treatment regimen, defined as a. failure to achieve PR or CR to at least one fludarabine-containing treatment regimen; or, b. disease progression while on a fludarabine-containing treatment regimen; or, c. disease progression in responders within 6 months of the last dose of a fludarabine-containing treatment regimen 2. Intolerant to fludarabine, defined as a. Discontinuation of therapy due to side effects/toxicity whether or not response occurred; or b. Ineligible to treatment with fludarabine due to history of previous fludarabine-induced autoimmune hemolytic anemia or autoimmune thrombocytopenia Failing at least one alemtuzumab-containing treatment regimen is defined as 1. Refractory to one alemtuzumab-containing treatment regimen, defined as a. failure to achieve PR or CR to at least one alemtuzumab-containing treatment regimen; or, b. disease progression while on a alemtuzumab-containing treatment regimen; or, c. disease progression in responders within 6 months of the last dose of a alemtuzumab-containing treatment regimen 2. Intolerant to alemtuzumab, defined as a. Discontinuation of therapy due to side effects/toxicity whether or not response occurred; or, b. Ineligible to treatment with alemtuzumab due to concurrent medical conditions, such as i. previous pneumocystis carinii pneumonia PCP ii. history of other severe opportunistic infections iii. repeated grade 3 or 4 infections of other types A patient must have failed at least one fludarabine-containing treatment regimen and one alemtuzumab-containing treatment regimen, as defined above. Patients must have received at least one alkylating therapy. Patients may have received at most five previous treatment regimens for B-CLL. Patients must have an ECOG Performance Status of 0 or 1 and a life expectancy of at least 4 months. The patients should be 8805; 18 years of age and have given informed consent. A patient must have failed at least one fludarabine-containing treatment regimen and one alemtuzumab-containing treatment regimen, as defined above. Patients must have received at least one alkylating therapy. Patients may have received at most five previous treatment regimens for B-CLL. Patients must have an ECOG Performance Status of 0 or 1 and a life expectancy of at least 4 months. The patients should be 8805; 18 years of age and have given 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

The most important exclusion criteria consist of more than two previous treatment regimens that included purine analogues e.g. fludarabine, cladribine, pentostatin , more than five previous treatment regimens for B-CLL, previous treatment with alemtuzumab within 6 weeks prior to Visit 1, autologous and allogeneic stem cell transplantation at any time, radioimmunotherapy at any time or anticancer therapy within 4 weeks prior to Visit 1 and known or suspected transformation of B-CLL.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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