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

Phase 3

Completed

Conditions: Blood Cancer
Chronic Lymphocytic Leukemia (B-CLL)
10025320

Registration Number: NL-OMON30130

Lead Sponsor: Genmab

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 3

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 active disease.;Active B-CLL is defined and confirmed according to the NCIWG guidelines 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 at least PR 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 at least PR 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
iv. lympadenopathy with at least one lymph node > 5 cm causing symptoms or compression and requiring therapy;A patient must have failed at least one fludarabine-containing treatment regimen and one alemtuzumab-containing treatment regimen, as defined above. Patients must have an ECOG Performance Status of 0, 1 or 2 and a life expectancy of at least 4 months.;The patients should be >= 18 years of age and have given informed consent.

Exclusion Criteria

The most important exclusion criteria consist of previous treatment with alemtuzumab within 6 weeks prior to Visit 1, previous autologous stem cell transplantation within 6 months prior to Visit 1, allogenic 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Objective response as measured over a 24 week period from start of treatment<br /><br>assessed by an Independent endpoints Review Committee (IRC) according to the<br /><br>NCIWG guidelines </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Duration of response, Progression Free Survival (PFS), Time to next B-CLL<br /><br>therapy, Overall survival, Reduction in tumor size, CD5+CD19+, CD5+CD20+ in<br /><br>peripheral blood, and expressions of CD19, CD20, CD55 and CD59 on CD45+CD5+<br /><br>cells, Constitutional symptoms (B-symtoms), Resolution of lymphadenopathy,<br /><br>Resolution of organomegaly,<br /><br><br /><br>Prognostic value of FISH-parameters, CD38+, VH mutational status, FC receptor<br /><br>polymorphisms, C1qA-276 mutation, β2 microglobulin, thymidin kinase,<br /><br>circulating CD20, antigen density,<br /><br><br /><br>Improvement in ECOG Performance Status, Improvement in hemoglobin, Improvement<br /><br>in thrombocytopenia, Improvement in neutropenia, Number of blood transfusions,<br /><br>Number of grade 3 and 4 infections, Number of autoimmune hemolysis</p><br>

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