Eradication of minimal residual disease (MRD) in chronic lymphocytic leukaemia (CLL) with alemtuzumab: a Phase II study

Phase 2

Completed

• Conditions: Chronic lymphocytic leukaemia (CLL); Cancer; Leukaemia

• Registration Number: ISRCTN23153249
• Lead Sponsor: eeds Teaching Hospitals NHS Trust (UK)

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28032335 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-20
• Study Completion: 2008-02-29
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

1. At least 18 years old
2. Written informed consent
3. Previous confirmation of B-cell CLL with a characteristic immunophenotype on peripheral blood flow cytometry
4. Creatinine and bilirubin <2 x upper limit of normal unless secondary to direct infiltration of the liver by CLL or haemolysis
5. Must have achieved a complete remission or good partial remission after therapy for CLL
6. At least six months since completing last therapy for CLL
7. Have detectable MRD, as shown by peripheral blood or bone marrow involvement or have attained an MRD negative remission. The latter group is eligible for registration and three-monthly monitoring for MRD relapse

Exclusion Criteria

1. Lymph nodes of 2 cm or greater in maximum diameter
2. Known Human Immunodeficiency Virus (HIV) positive
3. Active infection
4. Past history of anaphylaxis following exposure to rat or mouse derived Commonly Deleted Region (CDR)-grafted humanised monoclonal antibodies
5. Use of prior investigational agents within six weeks
6. Pregnancy or lactation
7. Central Nervous System (CNS) involvement with CLL
8. Mantle cell lymphoma
9. Other severe, concurrent diseases or mental disorders
10. Active secondary malignancy
11. Persisting severe pancytopenia due to previous therapy rather than disease (neutrophils <0.5 x 109/l or platelets <50 x 109/l)
12. Patients previously treated with allogeneic Stem Cell Transplantation (SCT)
13. Patients who previously failed alemtuzumab therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Rate of achieving MRD negativity in patients with low levels of MRD following conventional therapy or who relapse at an MRD level after a previous MRD negative remission<br> 2. Safety of alemtuzumab in the MRD positive setting<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Clinical response to alemtuzumab therapy by National Cancer Institute (NCI) Criteria<br> 2. Overall survival<br> 3. Pharmacokinetic profile of alemtuzumab in the MRD setting<br> 4. Safety and efficacy of repeated dosing as required to achieve sustained MRD negativity<br><br> Outcome of additional Monitoring Investigation (patients who are MRD negative at registration):<br> 1. Time to MRD relapse<br> 2. Effect of alemtuzumab used in a consolidation/maintenance approach on the expression of CD52 on CLL cells<br>