Alemtuzumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia in Partial Remission or Complete Remission

NCT00458523 | Completed Phase 2

• 6 other identifiers: LCC-CTRU-CLL207CDR0000538115SPRI-LCC-CTRU-CLL207ISRCTN23153249EU-20715EUDRACT-2006-000053-22
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. PURPOSE: This phase II trial is studying the side effects and how well alemtuzumab works in treating patients with B-cell chronic lymphocytic leukemia in partial remission or complete remission.

Conditions

Leukemia

Keywords

B-cell chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage 0 chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (2)

• Rate of undetectable minimal residual disease (MRD) after completion of alemtuzumab therapy

• Rate of unacceptable toxicities

Secondary Outcomes (8)

• Rate of overall response (complete or partial response)

• Time to MRD relapse

• Overall survival

• Expression of CD52 on chronic lymphocytic leukemia cells

• Rate of re-achievement of MRD negativity after completion of alemtuzumab therapy

Interventions

alemtuzumab BIOLOGICAL

fluorescence in situ hybridization GENETIC

mutation analysis GENETIC

flow cytometry OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) meeting the following criterion: * Confirmed by characteristic immunophenotype on peripheral blood flow cytometry * In complete or partial remission after prior therapy for B-CLL * No treatment failure after receiving prior alemtuzumab therapy * Minimal residual disease (MRD) status meeting 1 of the following criteria: * Detectable B-CLL MRD (i.e., MRD-positive) as shown by peripheral blood or bone marrow involvement * Undetectable B-CLL MRD (i.e., MRD-negative remission) * Lymph nodes \< 2 cm in maximum diameter * No persisting severe pancytopenia due to prior therapy rather than disease, as defined by the following criteria: * Neutrophil count \< 5,000/mm\^3 * Platelet count \< 50,000/mm\^3 * No clinically progressive disease (i.e., peripheral blood B-cell count ≥ 5,000/mm³) * No mantle cell lymphoma * No CNS involvement with B-CLL PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study therapy * Creatinine \< 2 times upper limit of normal (ULN)\* * Bilirubin \< 2 times ULN\* * No known HIV positivity * No concurrent active infection * No history of anaphylaxis after exposure to rat or mouse-derived, complementary-determining region-grafted humanized monoclonal antibodies * No other concurrent severe diseases or mental disorders * No concurrent active secondary malignancy NOTE: \*Unless secondary to direct infiltration of the liver by B-CLL or hemolysis PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior allogeneic stem cell transplantation * Any other prior therapy allowed * At least 6 months since completion of last therapy for B-CLL * More than 6 weeks since prior investigational agents * No other concurrent cytotoxic agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Leeds Cancer Centre at St. James's University Hospital: lead

Study Sites (2)

Kent and Canterbury Hospital

Canterbury, England, CT1 3NG, United Kingdom

Location

Leeds General Infirmary

Leeds, England, LS1 3EX, United Kingdom

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Alemtuzumab; In Situ Hybridization, Fluorescence; Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Cell Separation; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical

Study Officials

• Peter Hillmen, MD

  Leeds General Infirmary

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: December 1, 2006
• Study Completion: February 1, 2008
• Last Updated: August 12, 2013

Record last verified: 2007-04

Locations

GB (2)