We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00458523
First Posted: April 11, 2007
Last Update Posted: August 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Leukemia Biological: alemtuzumab Genetic: fluorescence in situ hybridization Genetic: mutation analysis Other: flow cytometry Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Eradication of Minimal Residual Disease (MRD) in Patients With Chronic Lymphocytic Leukaemia (CLL) With Alemtuzumab: A Phase II Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of undetectable minimal residual disease (MRD) after completion of alemtuzumab therapy
  • Rate of unacceptable toxicities

Secondary Outcome Measures:
  • 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
  • Incidence of successful retreatment
  • Toxicity from repeated therapy
  • Length of interval between required treatments

Estimated Enrollment: 54
Study Start Date: December 2006
Study Completion Date: February 2008
Detailed Description:

OBJECTIVES:

Primary

  • Determine the rate of achieving minimum residual disease (MRD) negativity after treatment with alemtuzumab in patients with B-cell chronic lymphocytic leukemia (B-CLL) who have low levels of MRD after conventional therapy or who relapse at an MRD level after a prior MRD-negative remission.
  • Determine the safety of alemtuzumab in patients treated in the MRD-positive setting.

Secondary

  • Determine the clinical response in patients treated with this drug.
  • Determine the time to MRD relapse in patients treated with this drug.
  • Determine the overall survival of patients treated with this drug.
  • Determine the effect of this drug when administered as consolidation/maintenance therapy on CD52 expression on CLL cells.
  • Determine the safety and efficacy of repeated drug dosing required to achieve sustained MRD negativity in these patients.

OUTLINE: This is a multicenter study.

  • Observation: Patients with minimal residual disease (MRD)-negative status are observed every 4 weeks for 12 weeks and then every 12 weeks thereafter. If they become MRD-positive, then they are eligible for treatment.
  • Treatment: Patients with MRD-positive status receive alemtuzumab subcutaneously or IV over 2 hours three times weekly for up to 12 weeks in the absence of disease progression or unacceptable toxicity. After completion of 6 weeks of study therapy, patients are evaluated for response. Patients who remain MRD-positive and are responding to study therapy receive an additional 6 weeks of treatment. Patients who remain MRD-positive and show no significant improvement in the level of leukemic cells detected in their peripheral blood or bone marrow are removed from the study. Patients achieving MRD-negative remission are removed from study therapy and monitored for disease recurrence at an MRD level. If MRD-level relapse is confirmed in these patients, they may be retreated with alemtuzumab provided their initial response to therapy lasted for at least 6 months.

Patients undergo collection of peripheral blood and bone marrow periodically during study for assessment of MRD by MRD flow cytometry, fluorescent in situ hybridization (FISH) analysis, somatic mutation analysis, and B-cell selection.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458523


Locations
United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT1 3NG
Leeds General Infirmary
Leeds, England, United Kingdom, LS1 3EX
Sponsors and Collaborators
Leeds Cancer Centre at St. James's University Hospital
Investigators
Study Chair: Peter Hillmen, MD Leeds General Infirmary
  More Information

ClinicalTrials.gov Identifier: NCT00458523     History of Changes
Other Study ID Numbers: LCC-CTRU-CLL207
CDR0000538115 ( Registry Identifier: PDQ (Physician Data Query) )
SPRI-LCC-CTRU-CLL207
ISRCTN23153249
EU-20715
EUDRACT-2006-000053-22
First Submitted: April 9, 2007
First Posted: April 11, 2007
Last Update Posted: August 12, 2013
Last Verified: April 2007

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Alemtuzumab
Antineoplastic Agents