Eradication of Minimal Residual Disease (MRD) in patients with Chronic Lymphocytic Leukaemia (CLL) with Alemtuzumab: A Phase II Study - UKCLL07

• Conditions: Chronica Lymphocytic Leukaemia (CLL)

• Registration Number: EUCTR2006-000053-22-GB
• Lead Sponsor: eeds Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

The following are necessary for entry:
•At least 18 years old.
•Be capable of giving written informed consent.
•Previous confirmation of B-CLL with a characteristic immunophenotype on peripheral blood flow cytometry.
•Creatinine and bilirubin <2 x upper limit of normal unless secondary to direct infiltration of the liver by CLL or haemolysis.
•Patients must have achieved a complete remission or partial remission after previous therapy for CLL (as defined by NCI criteria).
•Peripheral B-cell count should be less than 5 x 109/l.
•At least 6 months since completing last therapy for CLL.
•Have detectable MRD (MRD positive), as shown by peripheral blood or bone marrow involvement or have attained undetectable CLL (MRD negative remission). The latter group is eligible for registration and 3 monthly monitoring for MRD relapse.

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

Patients who meet any of the following criteria will be excluded:
•Lymph nodes of 2cm or greater in maximum diameter.
•Peripheral B-CLL count greater than 5 x 109/l. Patients must not have progressed clinically (peripheral B-CLL count should be less than 5 x 109/l.)
•HIV positive.
•Patient has active or prior Hepatitis B or C
• Active infection.
•Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanised monoclonal antibodies.
•Use of prior investigational agents within 6 weeks.
•Pregnancy, lactation or women of child-bearing potential unwilling to use medically approved contraception whilst receiving treatment.
•Men whose partners are capable of having children but who are not willing to use appropriate medically approved contraception during the study, unless they are surgically sterile.
•CNS involvement with CLL.
Mantle cell lymphoma.
•Other severe, concurrent diseases or mental disorders.
•Active secondary malignancy.
•Persisting severe pancytopenia due to previous therapy rather than disease (neutrophils <0.5 x 109/l or platelets <50 x 109/l).
•Patients previously treated with allogeneic SCT.
•Patients who previously failed alemtuzumab therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified